I:\MEPC\61\2-6.doc 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

61st session 

Agenda item 2 

MEPC 61/2/6

25 March 2010

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Application for Basic Approval of Kuraray Ballast Water Management System 

Submitted by Japan 

SUMMARY 

Executive summary: This document contains an application for Basic Approval of 

Kuraray Ballast Water Management System under the Procedure 

for approval of ballast water management systems that make use 

of Active Substances (G9) adopted by resolution MEPC.169(57) 

Strategic direction: 7.1 

High-level action: 7.1.2 

Planned output: 7.1.2.4 

Action to be taken: Paragraph 4 

Related documents: BWM/CONF/36; MEPC 53/24/Add.1; MEPC 57/21 and BWM.2/Circ.13 

Introduction

1 Regulation D-3.2 of the International Convention for the Control and Management of 

Ships' Ballast Water and Sediments stipulates that ballast water management systems that 

make use of Active Substances to comply with the Convention shall be approved by the 

Organization. 

2 Japan herewith submits an application for Basic Approval according to the 

"Procedure for approval of ballast water management systems that make use of Active 

Substances (G9)". This Procedure stipulates the required information (MEPC 57/21, annex 1, 

paragraph 4.2.1) which, according to section 6, should be evaluated by the Organization. 

In accordance with BWM.2/Circ.13, the document in the annex contains the non-confidential 

part of the manufacturer's application dossier including: 

.1 non-confidential information related to Kuraray Ballast Water Management 

System according to Procedure (G9); 

.2 list of references; and 

.3 quality control statement of each test. 
MEPC 61/2/6 

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The complete dossier will be made available to the experts of the GESAMP-BWWG with the 

understanding of confidential treatment. 

3 The receiving competent authority in Japan has verified the application dossier 

and believes it to satisfy the data requirements of Procedure (G9) adopted by 

resolution MEPC.169(57). 

Action requested of the Committee 

4 The Committee is invited to consider the proposal for approval and decide as 

appropriate. 

***
MEPC 61/2/6 

Annex, page 1 

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ANNEX 

NON-CONFIDENTAL INFORMATION ON KURARAY BALLAST WATER 

MANAGEMENT SYSTEM 

This annex has the following contents: 

1 INTRODUCTION 

2 APPLICATION DATA SET 

3 USE OF THE ACTIVE SUBSTANCE 

4 MATERIAL SAFETY DATA SHEETS 

5 RISK CHARACTERIZATION 

6 EVALUATION OF THE TREATED BALLAST WATER 

7 RISK ASSESSMENT 

8 CONCLUSION 

9 REFERENCES 

APPENDICES: 

APPENDIX 1 STATEMENT 

APPENDIX 2 QUALITY ASSURANCE STATEMENT 

1 INTRODUCTION 

1.1 Contents of the Basic Assessment Report 

This final Basic Assessment Report is prepared in accordance with the "Methodology for 

information gathering and the conduct of work of the GESAMP-BWWG" (BWM.2/Circ.13). 

1.2 Application conditions of the system 

The application for Basic Approval is to request permission for use of a ballast water 

management system (hereinafter referred to as "BWMS"). The conditions for Kuraray 

BWMS in this application are as follows: 

.1 Ballast water to be processed: Filling ballast water. 

.2 Number of times of ballast water treatments: Once. 

.3 Active Substance to be used and concentration: Calcium hypochlorite 

at 2 mg/L as free active chlorine (FAC). 

.4 Holding time: 0 h. 

.5 Operation of neutralization treatment device: When the FAC concentration in 

the discharge ballast water exceeds 0.2 mg/L, it is neutralized prior to being 

discharged by adding sodium sulfite. And, when the FAC concentration 

is 0.2 mg/L or less, it is discharged without neutralization. 
MEPC 61/2/6 

Annex, page 2 

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.6 Maximum allowable discharge concentrations of the Active Substance and 

Relevant Chemicals: Maximum allowable discharge concentration of FAC 

is 0.2 mg/L; calcium hypochlorite (the Active Substance of FAC) is lowered 

to 0.2 mg/L (as FAC) or less by the time of discharge. Maximum allowable 

discharge concentrations of Relevant Chemicals are estimated as the 

maximum detected concentration on the toxicity test as described below: 

Bromoform: 0.101 mg/L 

Dibromochloromethane: 0.002 mg/L 

Dichloromethane: 0.062 mg/L 

Monobromoacetic acid: 0.003 mg/L 

Dibromoacetic acid: 0.04 mg/L 

Tribromoacetic acid: 0.05 mg/L 

Dibromochloroacetic acid: 0.03 mg/L 

Monochloroamine: 0.2 mg/L (after neutralization: 0.02 mg/L, 

 as chloramines) 

Dichloroamine: 0.2 mg/L (after neutralization: 0.02 mg/L, 

 as chloramines) 

Trichloroamine: 0.2 mg/L (after neutralization: 0.02 mg/L, 

 as chloramines) 

Dibromoacetonitrile: 0.02 mg/L

1.3 Summary of the Basic Assessment Report 

Since the BWMS discharges the FAC at 0.2 mg/L or less, the risk to sea environment is 

considered to be within tolerance. Furthermore, it is considered not to have any harmful 

effects on ships or the human body. Therefore, the BWMS is considered suitable for 

proceeding to further development and putting forward various tests and procedures used for 

the Final Approval. 

2 APPLICATION DATA SET 

2.1 Identification of the Active Substance or Preparation (G9: 4.1) 

2.1.1 Preparation (G9: 4.2.2) 

The chemicals used in the BWMS are "Kuraray AS" of which calcium hypochlorite, as listed 

in Table 2.1-1, is the main component. 
MEPC 61/2/6 

Annex, page 3 

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Table 2.1-1: Composition of Kuraray AS infused into a ballast line in the BWMS 

*

 AS: Active Substance, RC: Relevant Chemicals, Other: Other Chemicals 

2.1.2 Active Substances (AS) 

The Active Substance used by the BWMS is calcium hypochlorite as described in 

section 2.1.1. The information on calcium hypochlorite is listed below. In addition, the 

concentration of calcium hypochlorite is represented by free active chlorine (FAC), which is 

the oxidizing power thereof except for the data set. 

.1 Trade name: Not applicable. 

.2 Chemical name: Calcium hypochlorite (calcium hypochlorite). 

.3 CAS number: 7778-54-3. 

.4 UN number and proper shipping name: 1748 (CALCIUMHYPOCHLORITE 

MIXTURE, DRY with more than 39% available chlorine). 

.5 Molar mass: 142.98. 

.6 Empirical formula: Ca(ClO)2.

.7 Structural formula: 

.8 Classification in accordance with the UN GHS system: 

(Based on REGULATION (EC) No. 1272/2008) 

Oxidising solids: Category 2, Acute toxicity: Category 4 

Skin corrosion: Category 1B, Aquatic toxicity: Category acute 1 

Composition of Kuraray AS

Component 

Chemical Name CAS Number Empirical formula 

Molar 

Mass 

Concentration 

(%) 

AS, RC or 

Other* 

Calcium 

hypochlorite 7778-54-3 Ca(ClO)2 142.98 ≥67 (as AvCl) AS 

Calcium hydroxide 1305-62-0 Ca(OH)2 74.09 ≤3 

Polyphosphoric acid 

sodium salt 68915-31-1 Na5P3O10 367.86 ≤0.5 

Sodium chloride 7647-14-5 NaCl 58.44 ≤12 

Calcium chloride 10043-52-4 CaCl2 110.98 ≤3 

Calcium chlorate 10137-74-3 Ca(ClO3)2 206.98 ≤1 

Calcium carbonate 471-34-1 CaCO3 100.09 ≤3 

Water - 18 to 24 

Other 

(Additives in 

Preparation) 
MEPC 61/2/6 

Annex, page 4 

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.9 Purity of the technical substance and identification of impurities (chemical 

name and CAS- number, etc.): See Table 2.1-1. 

.10 Identity of any stabilizer or necessary additives: Not applicable. 

2.1.3 Relevant Chemicals (RC) (G9: 2.1.4) 

When seawater and brackish water is treated by Kuraray AS, as prepared for the BWMS, the 

composition analysis results (the measurement is performed in a 10% solution of the treated 

water) are as represented in Table 2.1-2 (appendix 2 of this Basic Assessment Report; 

measurement at the time of the aqueous toxicity test). As a result, in addition to calcium 

hypochlorite, which is the Active Substances, (1) Bromoform, (2) Dibromochloromethane, 

(3) Dichloromethane, (4) Monobromoacetic acid, (5) Dibromoacetic acid, (6) Tribromoacetic 

acid, (7) Dibromochloroacetic acid, (8) Chloramine (Monochloroamine, Dichloroamine, or 

Trichloroamine), and (9) Dibromoacetonitrile are detected. For this reason, these nine 

substances are called the Relevant Chemicals in the BWMS. The substance information on 

the Relevant Chemicals is represented in Table 2.1-3. 
MEPC 61/2/6 

Annex, page 5 

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Table 2.1-2: Composition analysis results in treated water diluted to 10% 

Concentration in seawater 

(mg/L) 

Concentration in brackish water 

(mg/L) 

Chemical Name Detection 

limit 

(mg/L)

Min. 

concentration

Max. 

concentration

Detection 

limit 

(mg/L) 

Min. 

concentration

Max. 

concentration

Sodium Bromate 

(as bromate ion) 

Calcium Bromate 

(as bromate ion) 

0.01 N.D. N.D. 0.01 N.D. N.D. 

Calcium hypochlorite 

(as free active chlorine 

(FAC)) 

0.01 <0.01 0.02 0.01 <0.01 0.02 

Bromoform 0.0001 0.0017 0.0101 0.0001 0.0013 0.0020 

Chloroform 0.0001 N.D. N.D. 0.0001 N.D. N.D. 

Dibromochloromethane 0.0001 <0.0001 0.0002 0.0001 N.D. N.D. 

Dichlorobromomethane 0.0001 N.D. N.D. 0.0001 N.D. N.D. 

Dibromomethane 0.001 N.D. N.D. 0.001 N.D. N.D. 

Dichloromethane 0.0001 <0.0001 0.0062 0.0001 <0.0001 0.0004 

1,2-dibromo-3-chloro 

propane 0.0001 N.D. N.D. 0.0001 N.D. N.D. 

1,1,1-trichloroethane 0.0001 N.D. N.D. 0.0001 N.D. N.D. 

Tetrachloroethane 0.0001 N.D. N.D. 0.0001 N.D. N.D. 

1,2,3-trichloro propane 0.001 N.D. N.D. 0.001 N.D. N.D. 

Monochloroacetic acid 0.005 N.D. N.D. 0.0005 N.D. N.D. 

Dichloroacetic acid 0.002 N.D. N.D. 0.0001 N.D. N.D. 

Trichloroacetic acid 0.001 N.D. N.D. 0.0001 N.D. N.D. 

Monobromoacetic acid 0.001 N.D. N.D. 0.0001 <0.0001 0.0003 

Dibromoacetic acid 0.001 0.001 0.004 0.0001 0.0013 0.0019 

Tribromoacetic acid 0.001 0.003 0.004 0.0001 <0.0001 0.0050 

Bromochloroacetic acid 0.001 N.D. N.D. 0.0001 N.D. N.D. 

Bromodichloroacetic 

acid 0.001 N.D. N.D. 0.0001 N.D. N.D. 

Dibromochloroacetic 

acid 0.001 <0.001 0.003 0.0001 <0.0001 0.0003 

Monochloroamine 

(as chloramine) 

Dibromoamine 

(as chloramine) 

Trichloroamine 

(as chloramine) 

0.01 <0.01 0.02 0.01 0.02 0.02 

Dibromoacetonitrile 0.001 0.002 0.002 0.001 <0.001 0.001 

Chloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D. 

Dichloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D. 

Trichloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D. 

Bromochloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D. 

2-chlorotoluene 0.001 N.D. N.D. 0.001 N.D. N.D. 

4-chlorotoluene 0.001 N.D. N.D. 0.001 N.D. N.D. 

2,4-dibromophenol 0.001 N.D. N.D. 0.001 N.D. N.D. 

2,6-dibromophenol 0.001 N.D. N.D. 0.001 N.D. N.D. 

2,4,6-dibromophenol 0.001 N.D. N.D. 0.001 N.D. N.D. 

N.D.: Not detected. 
MEPC 61/2/6 

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Table 2.1-3: Information on Relevant Chemicals 

Chemical (IUPAC) Name CAS Number Molar mass Empirical formula Structural formula Classific

GHS sy

Bromoform 75-25-2 252.73 CHBr3

Acute TEye IttitaSkin irritAquatic 

Dibromochloromethane 124-48-1 208.28 CHBr2Cl Not avaDichloromethane 75-09-2 84.93 CH2Cl2

Carcino

Monobromoacetic acid 79-08-3 138.95 CH2BrCOOH 

Acute toSkin corAquatic 

Dibromoacetic acid 631-64-1 217.84 CHBr2COOH Not avaTribromoacetic acid 75-96-7 296.74 CBr3COOH 

Not ava

Dibromochloroacetic acid 5278-95-5 252.29 CBr2ClCOOH 

Not ava

Monochloroamine 10599-90-3 51.48 NH2Cl Not avaDichloroamine 3400-09-7 85.92 NHCl2 Not avaTrichloroamine 10025-85-1 120.37 NCl3 Not avaDibromoacetonitrile 3252-43-5 198.84 CHBr2CN 

Not ava

* Based on REGULATION (EC) No. 1272/2008. 
MEPC 61/2/6 

Annex, page 7 

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2.1.4 Other Chemicals (OC) 

When the FAC in the discharged ballast water is 0.2 mg/L or more, the BWMS neutralizes 

the FAC by adding sodium sulfite (purity >97%), which is twice as much as the FAC 

concentration, prior to discharging it. However, when the FAC concentration is 

below 0.2 mg/L, the sodium sulfite is not applied. 

In addition to sodium sulfite, additives in the preparation such as calcium chlorate, calcium 

hydroxide, calcium chloride, calcium carbonate and sodium polyphosphate are classified as 

Other Chemicals. Considering their content and properties, they are not used in the 

environment risk assessment. All the data are described in the complete dossier. 

2.2 Data on Effects on aquatic plants, invertebrates and fish, and other biota 

(including sensitive and representative organisms) (G9:4.2.1.1) 

This section describes data on effects on aquatic plants, invertebrates, fish, and other biota 

(including sensitive and representative organisms) of calcium hypochlorite, which is the 

Active Substance and bromoform, dibromochloromethane, dichloromethane, 

monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, 

chloramines, and dibromoacetonitrile which are the Relevant Chemicals. 

2.2.1 Acute aquatic toxicity 

2.2.1.1 Active Substance 

Even though the data on the acute toxicity test performed by a standard test method using 

calcium hypochlorite for fish are not acquired, a number of reliable data in a special test 

condition are acquired and the minimum 96-h LC50 is 23 μg TRC/L. For crustacea, 

Ceriodaphnia dubia, 24-h LC50 was 0.005 to 0.006 mg FRC/L (FRC = free available chlorine 

after a reaction). For algae, Thalassiosira pseudonana, 24-h LC50 was equal to 75 μg/L 

(20°C) (SIDS, 2004). 

Therefore, in this Basic Assessment Report, it is assumed that the acute aquatic toxicity of 

calcium hypochlorite used for various risk assessments of the aqueous environment 

is 0.005 mg FRC/L. 

2.2.1.2 Relevant Chemicals 

2.2.1.2.1 Bromoform 

The minimum value of LC50 for fish, Cyprinodon variegates, is 7.1 mg/L. The minimum value 

of LC50 for crustacea, Americamysis bahia, is 24.4 mg/L. For algae, there is data on EC50 

Skeletonema costatum and the minimum value is 12.3 mg/L. Therefore, it is assumed that 

acute aquatic toxicity of bromoform used for various risk assessments of the aqueous 

environment is 7.1 mg/L (U.S. EPA: ECOTOX Database 2007). 

2.2.1.2.2 Dibromochloromethane 

96-h LC50 for fish, oryzias latipes was 79 mg/L. 48-h EC50 for crustacea, Daphnia magna

was 27 mg/L. 96-h EC50 growth inhibition for algae, Pseudokircheneriella subcapitata, 

was 9.6 mg/L by speed calculation and 6.1 mg/L by area calculation (Ministry of the 

Environment in Japan, 1995). 
MEPC 61/2/6 

Annex, page 8 

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From the above description, it is assumed that the acute toxicity of the bromoform used in 

various risk assessments of the aqueous environment is 9.6 mg/L, as speed calculation is 

dominatingly adopted in growth inhibition of algae.

2.2.1.2.3 Dichloromethane 

The minimum value of LC50 for fish, Fundulus heteroclitu, is 97.0 mg/L. The minimum value 

of LC50 for crustacea, Palaemonetes pugia, is 108.5 mg/L. Even though there is the data 

on EC50 using algae, Pseudokircheneriella subcapitata and Bacillariophyceae, they both 

exceed 662 mg/L, which is not a definite value (EHC 164: IPCS, 1996). Therefore, it is 

assumed that the acute aquatic toxicity of the dichloromethane used in various risk 

assessments of the aqueous environment is 97.0 mg/L.

2.2.1.2.4 Monobromoacetic acid 

Data on acute toxicity test for fish is not acquired. 24-h EC50 that targets the 

swimming inhibition of crustacea, Daphnia magna, was 65 mg/L. 72-h EC50 that 

targets the growth inhibition of crustacea, Scenedesmus subspicatus, was 1.4 mg/L 

(ECOTOX Database 2010a). Therefore, it is assumed that the acute aquatic toxicity of 

bromoacetic acid used in various risk assessments of the aqueous environment is 1.4 mg/L. 

2.2.1.2.5 Dibromoacetic acid 

96-h LC50 using, fish, Pimephales promelas, was 69 mg/L. Data on acute toxicity test for 

crustacea and algae is not acquired (ECOTOX Database, 2010a). Therefore, it is assumed 

that the acute aquatic toxicity of the dibromoacetic acid used in various risk assessments of 

the aqueous environment is 69 mg/L.

2.2.1.2.6 Tribromoacetic acid 

Data on acute aquatic toxicity test of tribromoacetic acid for fish, crustacean and algae is not 

acquired.

2.2.1.2.7 Dibromochloroacetic acid 

Data on acute toxicity test of dibromochloroacetic acid for fish, crustacean and algae is not 

acquired.

2.2.1.2.8 Chloramines 

The minimum value of 96-h LC50 for fish, Menidia menidia, was 0.040 mg/L and the minimum 

value of LC50 for crustacea, Daphnia magna, was 0.011 mg/L. For algae, there is 10-d EC50 

data on Porphyra yezoensis and the minimum value was 0.014 mg/L. Further, 48-h EC50 for 

Crassostrea virginica was 0.001 mg/L (CEPA, 2001). Therefore, it is assumed that the acute 

aquatic toxicity of the chloramine used in various risk assessments of the aqueous 

environment is 0.001 mg/L. 

2.2.1.2.9 Dibromoacetonitrile 

96-h LC50 for algae, Pimephales promelas, was 0.55 mg/L (ECOTOX Database, 2010e). 

Data on crustacea and algae is not acquired. Therefore, it is assumed that the acute aquatic 

toxicity of dibromoacetonitrile used in various risk assessments of the aqueous environment 

is 0.55 mg/L. 
MEPC 61/2/6 

Annex, page 9 

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2.2.1.3 Treated ballast water (G9: 5.2.3) 

The acute toxicity of the ballast water treated by using the prototype test of the BWMS has a 

value that the effect on algae (Skeletonema costatum) in the brackish water condition under 

Guidelines (G8) for land-based testing is the most sensitive and ErC50 was calculated to 

be 5.8% dilution. In brackish water test, growth inhibition on algae, Skeletonema costatum, 

was observed in neutralization group with sodium sulfite addition. In the test, test water 

(treated water discharge: TWD) is prepared by dilution of the BWMS treated water (sodium 

sulfite injection concentration is 3 mg/L-FAC) to 10, 2, 0.4, 0.08 and 0.016%. Another test 

water (neutralization) is prepared by adding sodium sulfite to make 2 mg/L solution after 

diluting the treated water to 33v/v% with filtrated brackish water. 

In algae test, FAC in all the test water is below 0.01 mg/L. Regarding concentration of 

Relevant Chemicals in 10%-TWD and neutralization group, bromoform, dichloromethane and 

chloramines are detected but others are not detected. The maximum detected concentration 

of bromoform and dichloromethane during the algae test are 0.0013 mg/L and 0.0002 mg/L 

each. Acute toxic concentration of bromoform and dichloromethane are 7.1 mg/L and 97.0 mg/L 

each, as described before. The detected concentrations of the two chemicals are way below 

the acute toxicity level, while chloramines are detected as 0.2 mg/L in 10%-TWD group (less 

than 0.1 mg/L in neutralization group). The acute toxic concentration of chloramines 

is 0.001 mg/L as described before, and the detected concentration is 20 times as more. 

Therefore the effect on algae seems to be caused by the chloramines. 

2.2.2 Chronic aquatic toxicity 

2.2.2.1 Active Substance 

In fish, the minimum value of 133-d NOEC (No Observed Effect Concentration) of Ictalurus 

punctatus was 0.005 mg TRC/L (SIDS, 2004). 

As for other shellfish, 56-d of LC50 of Dreissena polymorpha (zebra mussel) was 0.08 mg/L 

and 15-d. NOEC of Crassostrea virginica (oyster) was 0.062 mg/L (SIDS, 2004). 

From the above description, it is assumed that the chronic aquatic toxicity of calcium hypochlorite 

used in various risk assessments of the aqueous environment uses 0.005 mg/L TRC/L. 

2.2.2.2 Relevant Chemicals 

2.2.2.2.1 Bromoform 

There is data on the chronic toxicity for fish, for example, Cyprinodon variegates and 28-d 

MATC (Maximum Acceptable Toxicant Concentration) is 4.8 mg/L (Ward et al, 1981). 96-h 

NOEC of algae, for example, Pseudokircheneriella subcapitata is 10 mg/L (ECOTOX, 2007). 

There was no data on crustacea. Therefore, it is assumed that the chronic aquatic toxicity of 

the bromoform used in various risk assessments of the aqueous environment uses the 

NOEC (MATC) of 4.8 mg/L. 

2.2.2.2.2 Dibromochloromethane 

There was no data on fish. There is data on the chronic toxicity that targets the breeding 

toxicity of crustacea, Daphnia magna and 21-d NOEC was 0.063 mg/L. 72-h NOEC of algae, 

Pseudokircheneriella subcapitata was 4.5 mg/L (Ministry of the Environment in Japan (1995)) 

Therefore, it is assumed that the chronic aquatic toxicity of the dibromochloromethane used 

in various risk assessments of the aqueous environment uses the NOEC of 0.063 mg/L. 
MEPC 61/2/6 

Annex, page 10 

I:\MEPC\61\2-6.doc 

2.2.2.2.3 Dichloromethane 

32-d NOEC that targets the growth including the initial life stage of fish, Pimephales 

promelas, was 82.5 mg/L (IPCS: EHC, 1996). Data on toxicity test for the crustacea and 

algae is not acquired. Therefore, it is assumed that the chronic aquatic toxicity of the 

dichloromethane used in various risk assessments of the aqueous environment uses the 

NOEC of 82.5 mg/L. 

2.2.2.2.4 Monobromoacetic acid 

There is data on the chronic toxicity that targets the breeding toxicity of crustacea, for 

example, Daphnia magna, and 21-d NOEC was 1.6 mg/L (ECOTOX Database 2010a). 

There was no data on fish and algae. Therefore, it is assumed that the chronic aquatic 

toxicity of the monobromoacetic acid used in various risk assessments of the aqueous 

environment uses the NOEC of 1.6 mg/L. 

2.2.2.2.5 Dibromoacetic acid 

Data (NOEC or MATC) on chronic toxicity of the dibromoacetic acid for fish, crustacea and 

algae is not acquired. 

2.2.2.2.6 Tribromoacetic acid 

Data (NOEC or MATC) on chronic toxicity of the tribromoacetic acid for fish, crustacea and 

algae is not acquired. 

2.2.2.2.7 Dibromochloroacetic acid 

Data (NOEC or MATC) on chronic toxicity of the dibromochloroacetic acid for fish, crustacea 

and algae is not acquired. 

2.2.2.2.8 Chloramines 

Data (NOEC or MATC) on the chronic toxicity of the chloramine is not acquired. 

2.2.2.2.9 Dibromoacetonitril 

Data (NOEC or MATC) on chronic toxicity of the dibromoacetonitrile is not acquired. 

2.2.2.3 Treated ballast water (G9: 5.2.3) 

The chronic toxicity of the ballast water treated by using the prototype test of the BWMS has 

a value that the effect on algae (Skeletonema costatum) in the brackish water condition 

according to Guidelines (G8) for land-based testing is the most sensitive one and 72h-NOEC 

is calculated to be 0.4% dilution. In brackish water test, growth inhibition on algae, 

Skeletonema costatum, was observed in neutralization group with sodium sulfite addition. 

In the test, test water (treated water discharge: TWD) is prepared by dilution of the BWMS 

treated water (sodium sulfite injection concentration is 3 mg/L-FAC) to 10, 2, 0.4, 0.08 

and 0.016%. Another test water (neutralization) is prepared by adding sodium sulfite to 

make 2 mg/L solution after diluting the treated water to 33v/v% with filtrated brackish water. 

In algae test, FAC in all the test water is below 0.01 mg/L. Regarding concentration 

of Relevant Chemicals in 10%-TWD and neutralization group, bromoform, dichloromethane 

and chloramines are detected but others are not detected. The maximum detected 

concentrations of bromoform and dichloromethane during the algae test are 0.0013 mg/L 
MEPC 61/2/6 

Annex, page 11 

I:\MEPC\61\2-6.doc 

and 0.0002 mg/L each. Chronic toxic concentration (NOEC) of bromoform and 

dichloromethane are 4.8 mg/L and 82.5 mg/L each, as described before. The detected 

concentrations of the two chemicals are way below the chronic toxicity level, while 

chloramines are detected 0.2 mg/L in 10%-TWD group (less than 0.1 mg/L in neutralization 

group). The chronic toxic concentration of chloramines is not reported, but the detected 

concentration is 20 times as more as the acute toxicity level. Therefore, the effect on algae 

seems to be caused by the chloramines. 

2.2.3 Endocrine disruption 

2.2.3.1 Active Substance 

The report that calcium hypochlorite shows the endocrine disruption for the aquatic is not 

acquired. 

2.2.3.2 Relevant Chemicals 

The report that the Relevant Chemicals such as bromoform, dibromochloromethane, 

dichloromethane, monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, 

dibromochloroacetic acid, chloramines, and dibromoacetonitrile show the endocrine 

disruption for the aquatic is not acquired. 

2.2.4 Sediment toxicity 

2.2.4.1 Active Substance 

The report that calcium hypochlorite has the sediment toxicity is not acquired. Calcium 

hypochlorite is an inorganic compound and although the half-life is changed depending on 

the conditions in water, it is rapidly degraded within several hours in seawater. Therefore, 

since calcium hypochlorite is not absorbed and accumulated in the sediment, it does not 

have sediment toxicity. 

2.2.4.2 Relevant Chemicals 

There was no information on the toxicity effect of all the Relevant Chemicals on the benthic 

zone. In addition, when it is determined based on methodology of the GESAMP-BWWG 

(MEPC 57/2/10, annex 4, paragraph 3.2.4), logPow of the Relevant Chemicals are 2.4 

(bromoform), 2.16 (dibromochloromethane), 1.25 (dichloromethane), 0.41 (monobromoacetic 

acid), 0.7 (dibromoacetic acid), 1.71 (tribromoacetic acid), 1.62 (dibromochloroacetic acid), 

and 0.47 (dibromoacetonitrile), and all of them are smaller than logPow of 3. Therefore, it is 

not considered that bromoform shows the sediment toxicity. For chloramines, they exist in 

water and are subjected to the hydrolysis due to the physicochemical property. Both of them 

are not considered to show the sediment toxicity.

2.2.5 Bioavailability/biomagnification/bioconcentration 

2.2.5.1 Active Substance 

The information on bioavailability/biomagnifications/bioconcentration of calcium hypochlorite 

is not acquired. Calcium hypochlorite is an inorganic compound and although the half-life is 

changed depending on by the conditions in water, it is rapidly degraded within several hours. 

Therefore, for calcium hypochlorite, it is considered that the bioavailability/biomagnifications/ 

bioconcentration is low. 
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2.2.5.2 Relevant Chemicals 

Data on the biomagnification/bioconcentration of the bromoform is acquired by a test for the 

fresh water fish, cyprinus carpio. In the test that cyprinus carpio was exposed to the 

bromoform of 0.1 mg/L and 0.01 mg/L, respectively, for 6 weeks, the BCF was 7.1 to 21 

and 7.7 to 19 (NITE, 2007). Therefore, it is determined that the possibility of 

biomagnification/bioconcentration is low. Further, if the logPow of the bromoform has a small 

value of 2.4, it meets the BCF very well. 

For other Relevant Chemicals, it is determined that the possibility of the 

biomagnification/bioconcentration is low. The logPow and BCF of each chemical is; 

logPow=2.16, BCF=9 (dibromochloromethane), BCF=2.0 to 5.4 and less than 6.4 to 40 

(dichloromethane), logPow=0.41, BCF=3.16 (monobromoacetic acid), logPow=0.7, 

BCF=3.16 (dibromoacetic acid), logPow=1.71 BCF=3.16 (tribromoacetic acid), 

logPow=1.62, BCF=3.16 (dibromochloroacetic acid), high solubility and reactivity 

(chloramines) and logPow=0.47, BCF=3.16 (dibromoacetonitrile). 

2.2.6 Food web/population effects 

2.2.6.1 Active Substance 

Since calcium hypochlorite has the low bioconcentration and is rapidly degraded in water, the 

possibility of the effect on the living things (algae, invertebrates and fish) configuring the 

food-web and the population is not considered. 

2.2.6.2 Relevant Chemicals 

BCF of the Relevant Chemicals such as bromoform, dibromochloromethane, 

monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid 

and dibromoacetonitrile are 21 or less. BCF of dichloromethane is less than 40 and 

considering other data possibility of bioconcentration is as low as other Relevant Chemicals. 

And the bioconcentration of chloramines is not considered due to the high aqueous solubility 

and reactivity. Therefore, since the bioaccumulation for all the living things (algae, 

invertebrates and fish) configuring the food-web is low, the possibility of the effect on the 

food-web/population is low for all the Relevant Chemicals. 

2.3 Data on Mammalian Toxicity (G9: 4.2.1.2) 

2.3.1 Acute toxicity 

2.3.1.1 Active Substance 

LD50 by oral administration of calcium hypochlorite to rat is 790 mg/kg bw (SIDS, 2004). 

No inhalation acute toxicity data of calcium hypochlorite is available. Inhalation of chlorine 

gas for 30 minutes gives LC01 to be 122 ppm for mouse and 420 ppm for rat (SIDS, 2004). 

For human, it is shown that NOAEL of acute toxicity is 0.5 ppm (1.5 mg/m3

) as chlorine 

concentration from several researches on volunteers (SIDS, 2004). 

2.3.1.2 Relevant Chemicals 

LD50 by oral administration of bromoform is 1400 to 1550 mg/kg bw in mouse and 

is 1147 to 1388 mg/kg bw in rat (IPCS, 2005). 
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For acute lethal action, bromoform is the lowest among bromine derived THM. Quantitative 

information was not acquired. Further, skin and ocular irritation, headache, dizziness, 

memory loss, loss of consciousness, convulsion, and pulmonary edema have been reported 

(US NLM: HSDB, 2003). 

As an example of accidental ingestion, central nervous system may be damaged which may 

induce a coma, areflexia, etc., and a small amount of bromoform leads to malaise, 

headache, and dizziness (ACGIH, 2001). Further, a case where human dies after oral 

ingestion of 143 mg/kg has been reported (U.S. NIOSH, 2002). 

LD50 by oral administration of dibromochloromethane is 800 to 1,200 mg/kg bw in mouse and 

is 848 to 1,186 mg/kg bw in rat (ATSDR, 2005). 

As the main symptom in the experimental animal after one-time oral administration, the 

central nervous system was damaged, including liver and kidney failure (ATSDR, 2005). 

LD50 by oral administration of dichloromethane is 1710 to 2250 mg/kg bw in mouse and LC50 

in inhalation exposure has 49100 to 55870 mg/m3 in mouse, has 52000 mg/m3 in rat, and 

has 40200 mg/m3 in marmot (ICPS: EHC, 1996). 

LD50 by oral administration of monobromoacetic acid is 177 mg/kg bw in male rat 

(IPCS: EHC, 2000). LD50 by endermatic application is 100 mg/kg bw in rat and is 59.9 mg/kg bw 

in rabbit (U.S.NLM: ChemIDplus, 2010). 

LD50 by oral administration of dibromoacetic acid is 1,737 mg/kg bw in male rat 

(IPCS: EHC, 2000). 

Data on acute toxicity of tribromoacetic acid and dibromochloroacetic acid is not acquired. 

LC50in inhalation exposure of trichloramine was 112 ppm (1 hour) in rat (U.S. NLM: 

ChemIDplus, 2010). 

LD50 by oral administration of dibromoacetonitrile to rodent was 245 to 361 mg/kg bw 

(WHO, 2004). 

2.3.2 Effects on skin and eye 

2.3.2.1 Active Substance 

Although calcium hypochlorite generally is known to have corrosivity for skin, data is not 

acquired (SIDS, 2004). Hereinafter, it is considered that calcium hypochlorite is associated 

with the mechanism of ocular irritation. 

The critical effect of calcium hypochlorite on eye is estimated by calcium positive ion and 

alkaline of non-reactive calcium hydroxide (at 1%FAC pH = 12.0) of non-reactivity. 

Hypochlorite ion has a case where pH is dominantly inclined to alkaline, while chlorine mainly 

exists at pH4 or less. The reason is that chlorine concentration in water is generally 

represented as FAC (chlorine that can be used freely) (Cl2 + HClO + ClO-

). These are 

caused by dissolved gas chlorine or dissolved hypochlorite.) (SIDS, 2004). 

Sensory organ irritation property of chlorine was evaluated by quantitatively reducing 

respiration rate after exposure for a short time in mouse and rat. In mouse, sensory organ 

irritation reaction was represented by 0.7 ppm (2.1 mg/m3

). After exposure for 60 minutes, 

50% reduction concentration (RD50) of number of respiration was 3.5 ppm (10.5 mg/m3

). 
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RD50 of mouse exposed for 10 minutes was 9.3 ppm (27.9 mg/m3). In rat and mouse, 

histological change due to the irritation after the exposure to chlorine of 9 ppm (27 mg/m3

) 

for 1, 3, 5 days mainly occurred in a nasal aperture and occurred in necrosis of epidermis, 

cell ablation, corrosion, ulceration squamous metaplasia (SIDS, 2004). 

In general, a large amount of toxicity that is shown in repetitive inhalation and endermatic 

exposure is of substantially irritation property (SIDS, 2004). 

2.3.2.2 Relevant Chemicals 

For skin irritation, when bromoform repeated contacts to skin of rabbit, there were reports 

that moderate irritation shows (ACGIH, 2001). Further, for irritation to human, there was a 

red flare symptom and there was a possibility that irritation is absorbed into body through the 

skin (IPCS, 2005). 

For ocular irritation, when bromoform undiluted solution is applied to the eye of rabbit, 

although moderate irritation was observed, there were reports that the irritation is recovered 

after 1 to 2 days. In addition, for ocular irritation of human, red flare symptom or pain is 

involved (IPCS, 2005). 

For skin irritation, when dichloromethane of 0.5 ml is applied to rabbit in a half-closed manner 

for 24 hours, severe red flare and edema leading to necrosis and acanthosis were observed 

in both damaged skin and normal skin. Further, when dichloromethane of 0.5 ml is applied 

to rabbit in a closed manner for four-hour patch, although moderate irritation was observed 

regardless of whether there were other chlorinated solvents, there was no skin corrosivity 

(IPCS: EHC, 1996). 

For ocular irritation, thickening of cornea, conjunctiva that leads to enhancement of 

intraocular pressure, moderate to severe inflammation of palpebra, and enhancement of 

intraocular pressure were observed in a test that drops a liquid dichloromethane of 0.1 ml to 

rabbit (in eyes of the rabbit). All the symptoms were reversible. The exposure of 

concentration of 17700 mg/m3

 shows light thickening of cornea and enhancement of 

intraocular pressure (IPCS: EHC, 1996). 

Irritation of liquid dichloromethane to skin and eye is intermediate (IPCS: EHC, 1996). 

Skin is immersed in chloramine aqueous solution having the concentration of 1 to 1000 mg/L 

for 10 minutes/day and hyperplasia of skin did not occur (IPCS: ECH, 2000). The test report 

on sensitization is not acquired. 

Report on irritation of dibromochloromethane, monobromoacetic acid, dibromoacetic acid, 

tribromoacetic acid and dibromochloroacetic acid to skin and eye is not acquired. 

2.3.3 Repeated-dose toxicity 

2.3.3.1 Active Substance 

In a test in which drinking water including calcium hypochlorite and hypochlorite Relevant 

Chemicals with a concentration of 0, 0.025, 0.05, 0.1, or 0.2 to 0.4% (NaClO) (equivalent 

to 0, 7, 14, 28, or 55 to 118 mg/kg bw/day) was administrated to rat for 13 weeks, although 

weight increase was suppressed in the maximum dose group in both male and female, 

histopathological change due to administration was not observed. From this, it was concluded 

that in the male, 0.1% NaClO (equivalent to 22.5 mg chlorine/kg bw/day) was NOAEL and in 

the female, 0.2% NaClO (equivalent to 55.6 mg chlorine/kg bw/day) was NOAEL (SIDS, 2004). 
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Annex, page 15 

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In a test in which drinking water including calcium hypochlorite and hypochlorite Relevant 

Chemicals with a concentration of 0, 25, 100, 175, or 250 mg chlorine/L (chlorine solution) 

(male: 0, 3.5, 12.6, 19.5, or 24.9 mg chlorine/kg bw/day, female: 0, 2.1, 7.5, 12.8, or 16.7 mg 

chlorine/kg bw/day) was administrated to male and female rats for 90 days, it was concluded 

that the toxicity effect was not observed even in any administrated group and the maximum 

dose group (250 mg/L in drinking water, 17 to 25 mg/kg bw/day) is NOAEL (SIDS, 2004). 

In a test in which drinking water including calcium hypochlorite and hypochlorite Relevant 

Chemicals with concentration of 0, 12.5, 25, 50, 100, or 200 mg chlorine/L (chlorine solution) 

(male: 0, 2.7, 5.1, 10.3, 19.8, or 34.3 mg chlorine/kg bw/day, female: 0, 2.8, 5.8, 11.7, 21.2, 

or 39.2 mg chlorine/kg bw/day) was administrated to male and female mice for 90 days, 

since the reduction in water ingestion dose was observed but the toxicity effect (the 

suppression of weight increase, the depression in organ weight, the depression in blood 

oxygen concentration) was not observed, it was concluded that 50 mg chlorine/L 

(10 to 12 mg chlorine/kg bw/day) was NOAEL (SIDS, 2004). 

2.3.3.2 Relevant Chemicals 

For the repeated-dose toxicity of bromoform, NOAEL that targets vacuolization of liver 

cell in forcible oral administration test using rat for 13 weeks is 25 mg/kg bw/day 

(IPCS: EHC, 2000). 

According to ICSC, it is indicated that the central nervous system and liver are affected by 

the repeated inhalation of bromoform and there was a possibility to damage tissue. 

For dibromochloromethane, NOAEL is 125 mg/kg bw/day (amended in the exposure 

situations: 89 mg/kg bw/day) (ATSDR, 2005). 

For dichloromethane, it was confirmed that vacuolization of liver cell occurs in a male group 

of 166 mg/kg bw/day or more (ATSDR, 2000; IPCS: EHC, 1996). 

For dibromoacetic acid, vacuolization of the liver cell was observed in a male group 

of 500 mg/L or more (U.S. NTP, 2007). 

For chloramines, NOAEL is 50 mg/L (WHO, 2004) and for dibromoacetonitrile, NOAEL 

is 200 mg/L (WHO, 2004). 

No reports are found on repeated-dose toxicity for monobromoacetic acid, tribromoacetic 

acid and dibromochloroacetic acid. 

2.3.4 Chronic toxicity 

2.3.4.1 Active Substance 

NOAEL of calcium hypochlorite on chronic toxicity is 22.5 mg chlorine/kg bw/day 

(SIDS, 2004). 

2.3.4.2 Relevant Chemicals 

In a test in which bromoform (solvent, cone oil) with a concentration of 0, 100, or 200 mg/kg 

bw/day and bromoform to mouse at a concentration of 0, 50, or 100 mg/kg bw/day was 

forcibly oral-administrated to rat for 103 weeks, fatty degeneration and chronic hepatic 

infiltration as nonneoplastic of liver were observed in the rat of male and female. Fatty 

degeneration was observed in the female mouse (IPCS, 2005). 
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In a test in which water including bromoform to F344 rat at a concentration of 0, 6.2, 29, 

or 57 mg/kg bw/day and to B6C3F1 mouse at 0, 8.3, 39, or 73 mg/kg bw/day for one year, 

since the effect on kidney (lesion of renal tubular and renal glomerulus) was mainly 

observed, it is described that the organ affected by bromoform is changed by solvent or dose 

method used in the test (IPCS, 2005). 

NOAEL of dibromochloromethane is 40 mg/kg bw/day (amended in the exposure 

situations: 29 mg/kg bw/day) (ATSDR, 2005). 

NOAEL of dichloromethane is 6 mg/kg bw/day (ATSDR, 2000). 

As a result of drinking water dose of dibromoacetic acid of 0, 50, 500, or 1,000 mg/L 

(male: equivalent to 0, 2, 20, or 40 mg/kg bw/day, female: equivalent to 0, 2, 25, or 45 mg/kg 

bw/day) to Fischer 344 rat of male and female for two years, nephropathy was observed in 

all exposure groups and alveolar epithelium hyperplasia was observed in female group 

of 500 mg/L or more (U.S.NTP, 2007). 

NOAEL of chloramines is 100 mg/L (male: equivalent to 9.8 mg/kg bw/day and female: 

equivalent to 10.6 mg/kg bw/day) (WHO, 2004). 

No reports are found on chronic toxicity for monobromoacetic acid, tribromoacetic acid and 

dibromoacetonitrile. 

2.3.5 Developmental and reproductive toxicity 

2.3.5.1 Active Substance 

In a test in which a chlorine solution with a concentration of 0, 1, 2, or 5 mg/kg bw/day 

(as HClO) (0, 0.7, 1.4, or 3.5 mg/kg bw/day (with effective chloride concentration)) was 

forcedly oral-administrated to male Long-Evance rat from 56 days ago to 10 days later of 

mating and orally administrated to female Long-Evance rat during mating, pregnancy, and 

breast-dietary duration (up to a 21st day after delivery) 14 days before mating, suppression 

of weight increase or hermatological change, toxic symptom, or the like was not observed in 

parent animals (male and female) of the administrated group. Further, in the male, a 

reproductive system including a sperm morphology defect was not changed and even in the 

female, administration was not influenced with respect to the length of pregnancy duration. 

And so forth, there was no dose-dependent effect on a reproductive rate, an embryo survival, 

the number of a litter of embryos, weight of children born, an eye-opening day, etc., and an 

estral cycle or a vaginal opening day were not related to the administration in F1 (SIDS,2004). 

In a test in which oral administration (drinking) of a chlorine (HClO) solution to a female SD 

rat with concentrations of 0, 0.7, 6.6, or 66 mg/L (with the effective chloride concentration) 

(equivalent to 0, 0.05, 0.5, or 5 mg/kg bw/day (with the effective chloride concentration)) during 

the pregnancy 2.5 months before conception and Cesarean section on the 20th day after the 

pregnancy was performed, there was no effect caused by the administration on the number of 

absorption embryos and embryo survival and there was no significant difference in occurrence 

frequency of skeletal abnormality and mutation between a control group and an administrated 

group. An embryonic weight has a slightly small value in a high-dose group (SIDS, 2004). 

2.3.5.2 Relevant Chemicals 

Concerning the developmental toxicity, in a test in which bromoform of 0, 50, 100, or 200 mg/kg 

bw/day was forcedly oral-administrated to a Sprague-Dawley rat (15 rats/groups) for 10 days 

including 6th to 15th days after the pregnancy of a Sprague-Dawley rat (15 heads/group) and 
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Annex, page 17 

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the outer shape, skeleton, and viscera of an embryo are observed by performing Caesarean 

operation at the end of pregnancy, the effects of the administration on the weight of a mother 

animal, the embryonic weight, and a pregnancy state are not recognized. The incidence of 

embryonic skeletal mutation (interparietal bone, ossifying delay of sternum core, and rib bone 14) 

has a tendency to increase, but the increase of visceral abnormality is not recognized. 

Further, it is reported that there is no effect of 50 mg/kg bw/day (Ruddick et al., 1983). 

In a test in which bromoform 150, or 200 mg/kg bw/day is forcedly oral-administrated to the 

F344 rat for 10 days including 6th to 15th days after pregnancy of an F344 rat, all embryos 

died in a dose in which toxicity is developed in the mother animal (Narotsky et al., 1992). 

Concerning the reproductive toxicity, bromoform of 50, 100, or 200 mg/kg bw/day is forcedly 

oral-administrated to male and female pairs of 20 sets of Swiss CD-1 mice for 105 days and 

in a test result for reproductive rate of mouse (fertility rate per pair, embryonic survival, weight, 

sexed imbalance, etc.), no effect of bromoform is observed (Ruddick et al., 1983). In a test 

in which bromoform of 1, 50, 100, or 200 mg/kg bw/day is forcedly oral-administrated to ICR 

mice (17 to 20 mice/group) for one week before mating, during 14-week continuous mating, 

and for three weeks thereafter (breeding is continuous up to mating and delivery of F2), 

suppression of weight increase was observed in males, a decrease of kidney weight, and an 

increase of liver weight can be observed in males and female of the 200 mg/kg bw/day group 

in F1, but no effect on fertility was observed (Gulati et al., 1989). 

Concerning the developmental toxicity, in a test in which dibromochloromethane of 0, 50, 100, 

or 200 mg/kg bw/day was forcedly oral-administrated to the rat during 6th to 15th days after 

the pregnancy, the weight increase of the mother animal was suppressed, but embryonic 

abnormality or mutation was not observed (WHO, 2005). 

Concerning the reproductive toxicity, a second-generation reproductive toxicity test 

(equivalent to average ingestion dose of 0, 17, 171, or 685 mg/kg bw/day) in which drinking 

water containing dibromochloromethane with a concentration of 0, 0.1, 1.0, or 4.0 mg/mL 

was administrated to male and female ICR-Swiss mice was performed and a conception rate 

(the number of pregnant animals/the number of mating animals × 100) and a pregnancy rate 

(the number of stomachs where children born exist/the number of pregnant animals × 100) 

decreased in a high-dose group with respect to the F1 generation and the conception rate 

decreased in the high-dose group of the F2 generation. Between both the F1 and 

F2 generations, the number of a litter of embryos, a survival rate, a feeding rate (the number 

of weaning babies/the number of surviving babies × 100), and the weight of a child born 

decreased in the high-dose group. No effect of dominant lethality or teratogenicity was 

observed in the F1 or F2 generation (WHO, 2005). 

Concerning the developmental toxicity, in an inhalation exposure test of dichloromethane of a 

concentration of 1,250 ppm (4,400 mg/m3

) to the SD rat or Swiss mouse on 6th to 15th days 

after the pregnancy, an increase of a CO-Hb value, an increase of liver weight was observed 

in mothers of the rat and the mouse, and an extensive increase of the pelvis of the kidney 

and ossifying delay of sternum in the embryo of the rat, and over sternum could be observed 

in the embryo of the mouse, but an increase of the number of developments of abnormality 

was not recognized. In an inhalation test of 4500 ppm (16,250 mg/m3) to LE rat for 21 days 

before pregnancy and for 17 days after pregnancy, abnormality of embryo was not observed. 

Furthermore, in the rat, even when a dose in which suppression of the weight of the mother 

animal is observed is forcedly oral-administrated during 6th to 15th days after the pregnancy, 

effect on the embryo was observed and abnormality was not appeared on mixed food 

dosage (IPCS: EHC, 1996). 
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Concerning the reproductive toxicity, after inhalation exposure of dichloromethane of 0, 100, 500, 

or 1,500 ppm (0, 350, 1,770, or 5,300 mg/m3

) to male and female rats (F344 and F0) 

for 14 weeks (6 hours/day and 5 days/week), which were mated, dichloromethane was 

exposed even to babies born (F1) for 17 weeks and in a test which F2 is acquired by mating, 

fertility potential, the number of births per one mother animal, a rearing situation of the baby, 

and survival rate are examined and according to a result of performing a histopathological 

test, abnormality up to the maximum exposure concentration (1,500 ppm) to all of F0, 

F1 (parent), F1, and F2 (baby) was observed (IPCS: EHC, 1996). 

In a test in which monobromoacetic acid of 0 and 100 mg/kg bw/day is forcedly 

oral-administrated to the male SD rat once and the male SD rat was killed in 2 or 14 days 

after the administration, no effect caused by the administration was observed in a histological 

examination of a genital organ weight, the number of sperms, a sperm shape, a fatality rate, 

and a seminiferous tubule. Further, even in a test in which monobromoacetic acid 

of 0 and 25 mg/kg bw/day is forcedly oral-administrated to the male rat for 14 days, no effect 

on the genital organ was observed (WHO, 2004). 

In a test in which dibromoacetic acid of 0, 10, 30, 90, or 270 mg/kg bw/day is forcedly 

oral-administrated to the male SD rat for 14 days, histopathological evidences of sperm 

discharge abnormality including a decrease of the number of sperms each with a head part, 

and an abnormal acrosomal development of a step-15 sperm cell and discharge delay of a 

step-19 sperm cell was observed in a 10 mg/kg bw/day-or more group. A decrease of the 

number of sperms each with a tail part, a deterioration of motility of the sperm, and an 

increase in occurrence frequency of an abnormal form of the sperm tail part was observed in 

a 90 mg/kg bw/day-or more group. A decrease in testicular weight and epididymis weight 

and an increase of head part abnormality of the sperm in a testis was observed in 

a 270 mg/kg bw/day group (WHO, 2004). 

In a test in which dibromoacetic acid of 0, 2, 10, or 50 mg/kg bw/day is forcedly 

oral-administrated to the male SD rat for 79 days, the male SD rat lives together with an 

untreated female one to one on 30th to 37th days and 49th to 56th days among 79 days, and 

the male SD rat lives together with the untreated females one (male) to two (female) 

on 65th to 71st days, no change, caused by the administration, of the administration can be 

the number of heads of propagable males, the number of a litter of embryos, an embryo 

weight, and the number of implantations was observed. In a group in which the male SD rat 

lives together with the untreated female one (male) to two (female), a mating frequency 

during a mating period decreased and the number of babies born of the female decreased 

with a concentration of 10 mg/kg bw/day or more. Further, at autopsy of the male's genital 

organism, degeneration of the seminiferous tubule in a 10 mg/kg bw/day or more groups was 

observed. From this result, NOAEL is 2 mg/kg bw/day (WHO, 2004). 

In a test in which water containing dibromochloroacetic acid is orally administrated to the male 

and female SD rats with concentrations of 0, 500, or 1500 ppm (male and female's average 

ingestion dose of dibromochloroacetic acid: equivalent to 0, 51, 89, or 112 mg/kg bw/day), 

a decrease of a water ingestion dose was observed in the male and female of a 1000 ppm-or 

more group and suppression weight increase was observed in 150 ppm of a non-pregnant 

female rat of a 150 ppm group. A decrease in sperm speed and a decrease in the maximum 

value of amplitude of lateral head displacement (ALH) were observed in the male of a 1500 ppm 

group (BrdU untreated) of the male. Meanwhile, in the BrdU-treated rat, an LI (labelling index) 

increased in the liver of the male of and the liver and kidney of the female of the 1500 ppm 

group. However, a histological change of the corresponding organism in the group was not 

observed. Further, in the pregnant rat, the reproductive toxicity was not observed and 

increase of the abnormality or mutation was not also observed (U.S. NTP, 2000). 
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Data on the developmental toxicity of chloramines is not acquired. Concerning the 

reproductive toxicity, in a test in which monochloramine of 0, 2.5, 5.0, or 10 mg/kg bw/day is 

forcedly oral-administrated to the male and female Long-Evans rats during the pregnant 

period and breast-feeding period from 66 to 76 days before the mating, there was no effect 

on the breeding potential, survival rate, the number of a litter of embryos, the average weight 

of children born, and the eye-opening day, which is caused by administrating test chemicals. 

Monochloramine has no effect on the sperm shape, a sperm's motion capability, etc., of the 

male and genital organism weights and autopsy of the genital organism of the male and 

female were also normal. From the result, NOAEL is 10 mg/kg bw/day (WHO, 2004). 

Concerning the developmental toxicity, in a test in which dibromoacetonitrile of 0, 50 mg/kg 

bw/day was forcedly oral-administrated to the female Long-Evans rats on 7th to 21st days 

after the pregnancy, suppression of weight increase of the mother animal was observed, 

embryonic absorption of dibromoacetonitrile increased, and the weight of the embryo had a 

low value in a 50 mg/kg group. From the result, LOAEL using mother animal toxicity and 

embryonic absorption increase rate as an indication is 50 mg/kg bw/day (WHO, 2004). 

Concerning the reproductive toxicity, in a test in which dibromoacetonitrile is 

drinking-administrated to the male and female SD rats with concentrations 0, 0.015, 0.050, 

or 0.15 g/L (male: equivalent to 0, 1.4, 3.3, or 8.2 mg/kg bw/day and female: equivalent 

to 0, 1.9, 5.3, or 10.8 mg/kg bw/day) for 34 days and the pregnancy period for the male and 

from 6th day after the pregnancy to 1st day after delivery for the female, no effect on the 

weight of the mother animal, autopsy, and the number of embryos which absorbing 

dibromoacetonitrile, which was caused by administration was observed. There was no effect 

on the weights, sex ratio, and survival rate of children born, and the number of a litter of 

embryos in the administrated group. A distance between the anus and the genitals on 

the 1st day after the delivery was normal. From the result, NOAEL is 8.2 mg/kg bw/day for 

male and 10.8 mg/kg bw/day for female (WHO, 2004). 

Test report on developmental and reproductive toxicity of tribromoacetic acid is not acquired. 

2.3.6 Carcinogenicity 

2.3.6.1 Active Substance 

The carcinogenicity of calcium hypochlorite is assessed by reporting a drinking 

administration test by hypochlorous acid (SIDS, 2004). 

Concerning the oral administration, a drinking administration test in which hypochlorous acid 

with concentrations of 0, 7, 140 or 275 mg/L is administrated to male and female B6C3F1 

mice and F344 rats is performed and in the result, the development rate of the tumour does 

not increase. However, in the female rat, there is no dosage dependence, but the 

development frequency of mononuclear cell leukaemia increased in medium and high dose 

groups. However, there was no significant difference in a death case due to the leukaemia 

between the control group and the administrated group (SIDS, 2004; U.S. NTP, 1992). 

Further, before publication of the test result by the NTP, the International Agency for 

Research on Cancer (IARC) classifies calcium hypochlorite as group 3 (not classifiable as to 

carcinogenicity to humans) (IARC, 199l). 

2.3.6.2 Relevant Chemicals 

Concerning the carcinogenicity of bromoform, although the development rate of the tumour 

for mouse does not increase in the oral administration test, a significant difference in the 

increase of the development rate of the large intestine tumour was recognized in only a high 
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dose of 200 mg/kg bw/day administrated to the rat. Further, since there is no data on human 

carcinogenicity and a limited evidence cannot be acquired from the animal, the IARC 

classifies bromoform as group 3 (not classifiable as to carcinogenicity to humans). Further, 

concerning the carcinogenicity of bromoform, the U.S. EPA uses a linearized multi-stage 

cancer model (LMS) as a non-threshold carcinogens substance with genetic toxicity and 

calculates a slope factor of 7.9 × 10-3 (mg/kg)-1 of an excessive cancer risk caused by oral 

ingestion according to a test result of the female rat (adenomatous polyps and 

adenocarcinoma of the large intestine (U.S. EPA, IRIS 2005). 

When dibromochloromethane of 0, 40 or 80 mg/kg bw/day was forcedly oral-administrated to 

male and female Fischer 344 rats for 2 years (5 days/week), the tumour of which the 

development rate significantly increases was not observed in any part (WHO, 2005). 

When dibromochloromethane of 0, 50 or 100 mg/kg bw/day was forcedly oral-administrated 

to male and female B6C3F1 mice for 2 years (5 days/week), a significant increase of liver 

cell cancer in the 100 mg/kg bw/day group of the male was recognized and the development 

rate of liver cell adenoma and the liver cell adenoma or cancer significantly increased even in 

the 100 mg/kg bw/day group of the female (WHO, 2005). 

Further, the IARC classifies the dibromochloromethane as group 3 (not classifiable as 

to carcinogenicity to humans, the carcinogenicity for the human cannot be evaluated) 

(IARC, 1991a). U.S. EPA classifies it as C (possibility carcinogenicity to human) 

(U.S. EPA IRIS, 1992). 

In a test in which dichloromethane of 0, 2000 or 4000 ppm was inhaled and exposed to male 

and female B6C3F1 mice for 102 weeks (6 hours/day and 5 day/week), shortening of the 

lifespan of both the male and female mice due to carcinogenesis of lung and liver was 

observed. In each exposure group including the control group, an increase of dose-dependent 

development of bronchoalveolar cancer was observed in both the male and female mice. 

Although the frequency of development of liver cell adenoma or liver cell cancer in the control 

group was high for the male mouse, the development of liver cell adenoma or liver cell 

cancer increased in a dose-dependent manner for the female mouse. In the exposure group 

to dichloromethane, an increase in the total number of developed cancers per an entity with 

the developed cancer in both the lung and the liver was observed (U.S. NTP, 1986). 

In a test in which dichloromethane with concentrations of 0, 1000, 2000 or 4000 ppm was 

inhaled and exposed to male and female F344/N rats B6C3F1 mice for 102 weeks 

(6 hours/day and 5 days/week), mammary gland tumour and fibroadenoma increase in the 

dose-dependent manner in both the male and female rats and subcutaneous fibroma around 

mammary gland and fibrosarcoma (for the only male rat) also increased. Tumour nodule of 

liver and the liver cell cancer slightly had a tendency to increase in the female rat, while the 

tendency was not present in the male rat. Further, in the male rats of all groups including the 

control group, the survival rate of the male rat was low at the time when the exposure period 

is terminated and a lot of deaths occurred within 16 weeks before the exposure period is 

terminated. In the test, it was considered that the reason why the death rate was high 

was that mononuclear leukaemia including the control group is developed at high rates 

(U.S. NTP, 1986). 

In a test in which dichloromethane of concentrations of 0, 50, 200 or 500 ppm was exposed 

to whole bodies of male and female SD rats for 2 years (6 hours/day and 5 day/week), an 

increase of hepatocyte vacuolation was observed in the male and female in the 500 ppm 

group and an increase of multinuclear hepatocyte was observed in the female and positive 

mammary gland tumour is developed at a development rate as high as a spontaneous 

development rate. Further, a malignant tumour was not observed (IPCS: EHC, 1996). 
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Further, U.S. EPA (1995) calculates an oral slope factor as 7.5 × 10-3 (mg/kg)-1, a unit risk in 

drinking as 2.1 × 10-7(μg/L)-1, and a unit risk in the inhalation exposure as 4.7 × 10-7(μg/m3)-1

(U.S. EPA, IRIS 1995). Furthermore, IARC classifies dichloromethane as group 2B 

(IARC, 1999b), ACGIH does as A3 (unknown for human but confirmed carcinogenicity for 

animal) (ACGIH, 2009), Japan Society for Occupational Health does as Group 2 (probably 

carcinogenicity to human with not enough proof) (J. of Occupational Health, 2009), U.S. EPA 

does as B2 (enough proof for carcinogenicity to animal; not enough proof for epidemiological 

research) (U.S.EPA IRIS, 1993), and U.S.NTP does as R (expected to be carcinogenic to 

human) (U.S.NTP, 2002). 

In a test in which a drink containing dibromoacetic acid of 0, 50, 500 or 1000 mg/L 

(male: equivalent to 0, 2, 20, or 40 mg/kg bw/day and female: equivalent to 0, 2, 25, 

or 45 mg/kg bw/day) was administrated to the male and female F344/N rats for 2 years, 

cystic degeneration of the liver increased in a full exposure male group. Further, 

mononuclear cell leukaemia was significantly increased in a male of the 50 and 500 mg/L 

male groups and a female of the 1000 mg/L female group (U.S. NTP, 2007). 

In a test in which a drink containing dibromoacetic acid of 0, 50, 500 or 1000 mg/L 

(male: equivalent to 0, 4, 45, or 87 mg/kg bw/day and female: equivalent to 0, 4, 35, 

or 65 mg/kg bw/day) was administrated to the male and female B6C3F1 mice for 2 years, 

liver tumour was developed in male and female exposure groups and a significant increase 

of the liver cell adenoma and the liver cell adenoma or cancer (binding form) was observed in 

the male of the full exposure group and the female of the 500 mg/L-or more group. 

Hepatoblastoma increased in the male of the 500 mg/L-or more groups and the liver cell 

cancer increased in the male of the 1000 mg/L group and the female of 500 mg/L groups. 

Although pneumocyte adenoma increased in both the male and the female, in particular, 

it significantly increased in the male of the 500 mg/L group (U.S. NTP, 2007). 

Further, the international organizations do not assess the carcinogenicity of dibromoacetic 

acid. 

IARC classifies chloramines as group 3 (Not classifiable as to carcinogenicity to humans) 

(IARC, 2004). Further, U.S. EPA classifies monochloramine as D (Not classifiable as to 

carcinogenicity to humans) (U.S. EPA IRIS, 1993). 

IARC assesses dibromoacetonitrile as group 3 (Not classifiable as to carcinogenicity to 

humans) (IARC, 1999). 

The test report on carcinogenicity of monobromoacetic acid, dibromochloroacetic acid and 

tribromoacetic acid is not acquired. Further, international organizations do not assess the 

carcinogenicity of the three bromoacetic acids. 

2.3.7 Mutagenicity/genotoxicity 

2.3.7.1 Active Substance 

When in vitro, chlorine/hypochlorous acid solution may have a certain kind of mutagenicity, 

while in vivo, it is concluded that chlorine/hypochlorous acid solution does not have 

mutagenicity (SIDS, 2004). 

2.3.7.2 Relevant Chemicals 

For bromoform, in vitro test, in a DNA-damaging test using a CHL cell and a CHO cell and 

the chromosome aberration test, opposite positive and negative results of genetic toxicity 

was observed. Further, in the DNA-damaging using the bacteria, the mutagenic test, the 
MEPC 61/2/6 

Annex, page 22 

I:\MEPC\61\2-6.doc 

chromosome aberration test using fungus, and a genetic mutation test using a mouse 

lymphoma cell, the positive result was observed. Furthermore, in vivo test, the positive result 

was acquired in the SCE test using the mouse and the micronuclear test, such that 

bromoform is considered to be chemicals having the genetic toxicity (Anderson et al., 1990; 

Fujie et al., 1990, Hayashi et al., 1988, LeCurieux et al., 1995, Matsui et al., 1989, Mirsalis 

et al., 1989, Myhr et al., 1990; NTP, 1989; Pereira et al., 1982, Rapson et al., 1980; Simmon 

et al., 1977, Simmon and Tardiff, 1978, Stocker et al., 1997, Zeiger, 1990). 

For Dibromochloromethane, in an in vitro test system, there are both a report that genetic 

mutation was induced in salmonella typhimurium and a report that the genetic mutation was 

not induced and the genetic mutation was induced in the mouse lymphoma cell (L5178Y), 

while the genetic mutation was not induced in yeast. The sister chromatid exchange was 

induced in a human lymphoid cell of the human, a rat liver cell, and a rat erythroblastic 

leukaemic cell, chromosome aberration was induced in the mouse lymphoma cell (L5178Y) 

and the Chinese hamster lung cell, and DNA strand cleavage was induced in a human acute 

lymphoblastic leukaemia cell, but the DNA strand cleavage was not induced in primary 

hepatocytes of the rat (ATSDR, 2005). 

In an in vivo test system, the system chromatid exchange was induced in oral-administrated 

bone marrow of the mouse and the chromosome aberration was induced in oral-administrated 

or intraperitoneally administrated bone marrow of the marrow, but micronuclear was not 

induced in intraperitoneally administrated bone marrow of the mouse, unscheduled DNA 

synthesis was not induced in oral-administrated liver of the rat, and the DNA strand cleavage 

was not induced in the liver, kidney, and duodenum (ATSDR, 2005). 

For dichloromethane, in the in vitro test system, the genetic mutation was induced in 

salmonella typhimurium regardless of the metabolic activation system. In the Chinese 

hamster lung cell (V79), the genetic mutation was not induced under non-existence of the 

metabolic activation system, but a slight increase of the frequency of the sister chromatid 

exchange was recognized. In the Chinese hamster ovary cell (CHO), the sister chromatid 

exchange was not induced. Although cross-link formation between DNA and protein was 

induced in a liver cell of a mouse having a GSTT1 gene function, it was not induced in the 

lung cell of the mouse, the liver cell of the hamster, and the lung cell of the hamster 

(IPCS: EHC, 1996). 

In the in vivo test system, in the inhalation exposure test to the mouse, the sister chromatid 

exchange was induced in the lung cell and slight micronuclear induction in peripheral blood 

erythrocyte was recognized, but the sister chromatid exchange micronuclear and 

chromosome aberration were not induced in the bone-marrow cell in oral, intraperitoneal, 

or subcutaneous administration to the mouse. Further, in drosophila, sex-linked recessive 

lethal mutation is not induced (IPCS: EHC, 1996). 

For monobromoacetic acid, in the in vitro test system, the positive was induced in an S9 

additive system of the genetic mutation test using TA98 and TA100 of salmonella 

typhimurium and the DNA damaging was induced in the mouse leukaemia cell, but the 

negative was observed in SOS chromo test using Escherichia coli and a micronuclear test 

using red blood cells of newt (US NLM: HSDB, 2010; WHO, 2004).

For dibromoacetic acid, in the in vitro test system, the positive was observed in TA100 of the 

genetic mutation test using salmonella typhimurium and in TA98, the negative was observed. 

Further, in the SOS chromo test using Escherichia coli, the positive was observed, but in the 

micronuclear test using the red blood cells of newt, the negative was observed (WHO, 2004). 
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In the in vivo test system, in a test in which dibromoacetic acid was drinking-administrated to 

male and female mice for 3 months and peripheral blood erythrocyte was examined, 

induction of micronuclear was observed in the male and it was not observed in the female 

(U.S. NTP, 2007). 

For tribromoacetic acid, in the in vitro test system, in the genetic mutation test using 

salmonella typhimurium, the positive was observed, but even in the SOS chromo test using 

Escherichia coli, the positive was observed (IPCS: EHC, 2000). 

For monochloramine, in the in vitro test system, in the genetic mutation test using salmonella 

typhimurium, the slightly positive or negative was observed and in the genetic mutation test 

using the mouse lymphoma cell, the positive was observed as the S9 additive-free system 

(WHO, 2004). 

In the in vivo test system, in the micronuclear test using the intraperitoneally administrated 

bone marrow cell of the mouse and the chromosome aberration test, the negative was 

observed and even in the micronuclear test using the oral-administrated marrow cell of the 

mouse, the negative was observed (WHO, 2004). 

According to these results, monochloramine may show the mutagenicity in the in vitro

system, but does not show the significant mutagenicity in the in vivo system (WHO, 2004). 

For dibromoacetonitrile, in the in vitro test system, in the genetic mutation test using 

salmonella typhimurium, the negative was observed and in the SOS chromo test using 

Escherichia coli, the DNA damaging shows an equivocal result (WHO, 2004). 

In the in vivo test system, in both the micronuclear test in the oral administration to the 

mouse and the DNA binding test in the oral administration to the rat, the negative was 

observed (WHO, 2004). 

Data on mutagenicity/genetic toxicity of dibromochloroacetic acid is not acquired.

2.3.8 Toxicokinetics 

2.3.8.1 Active Substance 

Data on toxicokintetics of calcium hypochlorite is not acquired. 

2.3.8.2 Relevant Chemicals 

In the test in which bromoform is forcedly oral-administrated to the rat, bromoform is rapidly 

absorbed and distributed to the liver, brain, kidney, and fatty tissue. Up to 8 hours after the 

administration, 67% and 4% of the administrated dose are discharged as unchanged 

bromoform and carbon dioxide, in the expired breath, respectively. Only 4% is discharged 

through the urine and a remaining dose in the tissue is low as 2%. Meanwhile, in the mouse, 

up to 8 hours after the administration, approximately 6% and approximately 40% of the 

administrated dose are discharged as unchanged bromoform and carbon dioxide, in the 

expired breath, respectively. Further, 5% is discharged through the urine and a remaining 

dose in the tissue is 8% (IARC, 1999a). 

In general, trihalomethane is rapidly absorbed and primarily metabolized into carbon dioxide, 

and thereafter, rapidly discharged. Among them, it is considered that bromoform has 

comparatively low toxicity and carcinogenicity by determination from the animal test. As one 

of the causes, it is considered that since bromoform is comparatively lipophilicity, biological 

availability is low (IPCS, 1996; NTP, 1989). 
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According to a result in which dibromochloromethane was forcedly oral-administrated to the 

rat with 100 mg/kg and the mouse with 150 mg/kg, the rat discharged 18% as carbon dioxide 

and 48% as unchanged dibromochloromethane and the mouse discharged 72% as carbon 

dioxide and 12% as unchanged dibromochloromethane in the expired breath. Radioactive 

activations which remain in principal organs of the rat and the mouse main were 1.4% 

and 5.0%, respectively, and both the rat and the mouse discharged less than 2% through the 

urine. The half-life of the dibromochloromethane was 1.2 hours in the rat and 2.5 hours in 

the mouse (WHO, 2005). 

Inhaled dichloromethane is rapidly absorbed in the lung or digestive tract and most of 

dichloromethane is discharged as unchanged dichloromethane in the expired breath. The 

rest other than unchanged dichloromethane is metabolized as carbon oxide, carbon dioxide, 

and inorganic chloride. In the case of high-concentration exposure, except for the metabolism, 

metabolism including glutathione transferase (GST) is made and dichloromethane including 

GST is metabolized to carbon dioxide through formaldehyde and formic acid. This route 

operates when oxidative metabolic route is saturated (IPCS: EHC, 1996). 

When dibromoacetic acid is forcedly oral-administrated to the rat, it is estimated that blood 

concentration reaches the maximum in 1 hour after the administration and dibromoacetic 

acid is rapidly absorbed. Although body distribution is unclear, protein binding or 

accumulation in blood cells by intracavernous administration is not recognized. It is 

anticipated that dibromoacetic acid is metabolized as glyoxylic acid from the in vitro test 

result, etc., and furthermore, metabolized as glycolate, oxalate, glycine, and carbon dioxide 

and rapidly discharged. Further, dibromoacetic acid has placental permeability and is 

detected as high as plasma concentration of the mother animal even in embryonic blood 

plasma, but is not detected in breast milk (WHO, 2004). 

Monochloramine oral-administrated to the rat is rapidly absorbed in the digestive tract. In the 

human, most of monochloramine ingested from drink reaches the stomach, but monochloramine 

loosened from the stomach does not enter a body circulation system. In 5 days after the 

administration, chloride ions are detected from whole blood, skin, testis, etc. Monochloramine 

is metabolized as chloride ions and primarily discharged to the urine (WHO, 2004). 

Although data on the biological fate of dibromoacetonitrile is not acquired, after 

dichloroacetonitrile is orally administrated to the rat and the mouse, dichloroacetonitrile is 

absorbed in the digestive tract through verification in the feces. 

It is known that halogenated acetonitrile is formed in vivo after chlorinating water is ingested, 

such that dichloroacetonitrile and dibromoacetonitrile were detected from the stomach of the 

rat after sodium hypochlorite/potassium bromide was orally administrated. It is probably 

considered that dichloroacetonitrile and dibromoacetonitrile are produced by reacting with 

organic compounds in the stomach (WHO, 2004). 

Data on toxicokintetics of monobromoacetic acid, tribromoacetic acid and dibromochloroacetic 

acid is not acquired. 

2.4 Data in Environmental Fate and Effect under Aerobic and Anaerobic Conditions 

(G9: 4.2.1.3) 

2.4.1 Modes of degradation (biotic; abiotic) 

2.4.1.1 Active Substance 

Calcium hypochlorite, which is the Active Substance, is dissociated into calcium and 

hypochlorite ions in water and the hypochlorite ion is rapidly degraded. The rate of 

degradation is influenced by temperature, pH, light and impurities (metal, salt). 
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Calcium hypochlorite solution is very sensitive to light, such that phase transition and 

degradation are caused by direct sunlight and thus chlorine and oxygen are produced. 

In atural waters, hypochlorite ions and chlorine molecules are unstable due to existence of 

inorganic and organic matter. The half-life of hypochlorite in the water is considered to be 

less than 2 hours by inorganic degradation and photolytic degradation (SIDS, 2004). 

Since calcium hypochlorite is an inorganic substance, biodegradability cannot be measured. 

In water, a degradation by-product of calcium hypochlorite is calcium chloride in the 

presence of organic substances (SIDS, 2004). 

2.4.1.2 Relevant Chemicals 

It is estimated that when the conditions allow for long-term acclimation at low concentrations, 

bromoform can be biodegraded. Furthermore, it is estimated that even under anaerobic 

conditions, when the concentration of bromoform is low, bromoform is biodegraded. 

Furthermore, since bromoform does not have chemical binding, which is easily hydrolyzed, 

bromoform is not hydrolyzed in a water environment (NITE, 2007, Tabak et al., 1981, Bouwer 

and McCarty, 1983b). 

In water, dibromochloromethane is comparatively stable, the hydrolysis rate constant is 

estimated to be 3.2 ×10-11/sec, and the hydrolysis half-life is reported to be 274 years 

(ATSDR, 2005). 

Under aerobic conditions, the biodegradability is low (10 to 15%). However, there is a 

possibility that the degradation rate will slightly increase after the acclimation of the bacteria. 

Furthermore, under anaerobic conditions, dibromochloromethane is slowly degraded by 

methanogenic bacteria (ATSDR, 2005). 

It is reported that dichloromethane is difficult to hydrolyze in natural environmental waters 

and the shortest hydrolysis half-life is 18 months. Since dichloromethane does not absorb 

light having a wavelength of 290 nm or greater, even though dichloromethane is exposed to 

sunlight for 1 year or more, dichloromethane is not photodegraded in surface waters 

(NEDO, 2005). 

In an aerobic biodegradation test using a modified culture bottle for volatile substances 

according to the Law Concerning the Examination and Regulation of Manufacture, etc., of 

Chemical Substances, the degradation rate of dichloromethane by following biological 

oxygen demand (BOD) is 13% under test conditions substrate of 100 mg/L, activated sludge 

concentration of 30 mg/L, and time period of 4 weeks, by which dichloromethane was 

determined to be persistent. Furthermore, using a gas chromatograph (GC) for 

measurement, the degradation rate was only 1%. On the other hand, it is reported that 

under natural environmental conditions, the biodegradation rate increases. It is also reported 

that in the test using anaerobic bacteria, the degradation half-life was 11 days (NEDO, 2005). 

Dichloromethane was fully degraded in a sewage treatment plant (activated sludge process) 

for 6 hours to 7 days. Furthermore, it is reported that an elimination rate in the sewage 

treatment plant was 95% (volatilization: 2.6% and bioconversion: 92.4%) (NEDO, 2005). 

From the above, it is considered that dichloromethane can be biodegraded under natural 

environmental conditions, anaerobic conditions and at sewage treatment plant, but not be 

biodegraded in practical environment. 

Since monobromoacetic acid has no hydrolytic substituent, monobromoacetic acid is not 

considered hydrolyzed in the environment (US NLM: HSDB, 2010a). 
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In an OECD TG301D (closed bottle) test with monobromoacetic acid at a concentration 

of 2 mg/L using acclimated sludge, 82% of monobromoacetic acid was degraded. In another 

report using not-acclimated sludge, however, monobromoacetic acid was said to have 

no biodegradability (US NLM: HSDB, 2010a). 

Since dibromoacetic acid has no hydrolytic substituent dependency, dibromoacetic acid is 

not considered hydrolyzed in the environment (US NLM: HSDB, 2010). 

Although data of biodegradability is limitative, in a test using dibromoacetic acid of a 

concentration of 5 mM as a carbon source, halogenated compounds were produced at 30°C 

after 10 days (US NLM: HSDB, 2010). 

Since tribromoacetic acid has no hydrolytic substituent, tribromoacetic acid is not considered 

hydrolyzed in the environment (US NLM: HSDB, 2010i). 

In a test using tribromoacetic acid of a concentration of 0.1 w/v-% as the carbon source, 

halogenated compounds were produced at 30°C after 20 days, but growth of bacteria was 

not recognized (US NLM: HSDB, 2010). 

Although information on degradability of dibromochloroacetic acid was not acquired, it is 

considered that hydrolysis and biodegradation of dibromochloroacetic acid does not occur 

(or is very slow), as is also the case for halogenated acetic acid having a similar structure. 

In water, chloramine compounds (mono, di, and trichloroamine) hydrolyze and vanish away 

very rapidly. When chloramines are hydrolyzed in water, the number of chlorines decreases 

and other chloramine forms are formed (CEPA, 2001). 

In water, dibromoacetonitrile is hydrolyzed by a basic catalyst or chlorine, even though no 

data is available on biodegradation. It is reported that the half-life of the hydrolysis is 2 days 

at a pH of 8.7. In tap water, it is reported that the concentration of dibromoacetonitrile 

decreased to 20 to 50% during delivery of the water (US NLM: HSDB, 2010f). 

2.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient 

2.4.2.1 Active Substance 

Bioaccumulation of calcium hypochlorite can be disregarded due to its aqueous solubility and 

reactivity. Further, hypochlorite ions are found in living bacteria (SIDS, 2004). 

In addition, since calcium hypochlorite is the inorganic matter, an octanol/water partition 

coefficient is not applied. 

2.4.2.2 Relevant Chemicals 

In a test for cyprinus carpio, BCF of bromoform is 21 at a maximum (NITE, 2007) and it is 

determined that bromoform does not have the bioaccumulation. Further, a value of logPow 

of bromoform is small as 2.4, which dovetails well with the result. 

BCF of Dibromochloromethane is estimated to be 9 from the octanol/water partition 

coefficient (logPow = 2.16) and it is considered that the bioaccumulation is low 

(US NLM: HSDB, 2010). 
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In a 6-week bioconcentration test using cyprinus carpio of the Law Concerning the 

Examination and Regulation of Manufacture, etc., of Chemical Substances, the concentration 

rates of dichloromethane in water concentrations of 0.25 mg/L and 0.025 mg/L are 2.0 to 5.4 

and less than 6.4 to 40, respectively, and it is determined that dichloromethane has no or low 

bioconcentration (NEDO, 2005). 

BCF of monobromoacetic acid is estimated to be 3.16 from the octanol/water partition coefficient 

(logPow = 0.41) and it is considered that bioaccumulation is low (US NLM: HSDB, 2010). 

BCF of dibromoacetic acid is calculated to be 3.16 from the octanol/water partition coefficient 

(logPow = 0.70) and it is considered that bioaccumulation is low (US NLM: HSDB, 2010e). 

BCF of tribromoacetic acid is calculated to be 3.16 from the octanol/water partition coefficient 

(logPow = 1.71) and it is considered that bioaccumulation is low (US NLM: HSDB, 2010i). 

BCF of dibromochloroacetic acid is calculated to be 3.16 from the octanol/water partition 

coefficient (logPow = 1.62) and it is considered that bioaccumulation is low (SRC, 2009). 

Bioaccumulation of chloramines is not considered due to high aqueous solubility and 

reactivity of chloramines. 

BCF of dibromoacetonitrile is estimated to be 3.16 from the octanol/water partition coefficient 

(logPow = 0.47) and it is considered that the bioaccumulation is low (US NLM: HSDB, 2010). 

2.4.3 Persistence and identification of the main metabolites in the relevant media 

(ballast water, marine and fresh water) 

When ballast water is treated in Kuraray AS as the Preparations, which uses calcium 

hypochlorite as a main component, 9 chemicals are produced as Relevant Chemicals (see 

section 2.1.3). Data including the identifications of persistence of the chemicals is organized 

in Table 2.4-1. 

In addition, calcium hypochlorite of the Active Substance does not correspond to the 

persistence (see section 2.4.1.1), either. 

Table 2.4-1: Persistence and identification of principal degradation product 

 Method Result Reference/Comments/Justification for 

missing data 

Bromoform N/A Persistent 

Section 2.4.1.2.1; not hydrolyzed. Under 

partial anaerobic conditions, it is further 

degraded, but it is difficult to be 

biodegraded under the aerobic environment.

Dibromochloromethane N/A Persistent ATSDR 2005, Section 2.4.1.2.2 

Dichloromethane N/A Persistent NEDO 2005, Section 2.2.1.2.3 

Monobromoacetic acid N/A Persistent US NLM: HSDB 2010a, Section 2.4.1.2.4 

Dibromoacetic acid N/A Persistent US NLM: HSDB 2010e, Section 2.4.1.2.5 

Tribromoacetic acid N/A Persistent US NLM: HSDB 2010i, Section 2.4.1.2.6 

Dibromochloroacetic acid N/A Persistent Section 2.4.1.2.7 

Chloramine N/A Easily 

degraded 

CEPA 2001, Section 2.4.1.2.8 

Dibromoacetonitrile N/A Persistent Section 2.4.1.2.9 

N/A: Not Available. 
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2.4.4 Reaction with organic matter 

2.4.4.1 Active Substance 

Free available chlorine rapidly reacts with the inorganic matters and the organic matters in 

natural water and chlorinated/oxidized by-product such as chloramine or chloromethane is 

produced (SIDS, 2004). 

Calcium hypochlorite reacts with dissolved organic matters in the water and produces 

various halogenated by-products. They include trihalomethane type (THMs), halogenated 

acetic acid type (HAAs), halogenated acetonitrile type (HANs), chloral hydrate, chloropicrin, 

etc. (IPCS, EHC, 2000). Calcium hypochlorite reacts by three routes in the water; oxidation, 

reaction-addition and reaction-substitution reactions. Since chlorine ions are easily 

substituted with bromine ions in the water, inorganic matters in which chloride, bromide, or 

both chlorine and bromine are substituted are produced (IPCS, EHC, 2000). 

2.4.4.2 Relevant Chemicals 

Bromoform as a kind of THM is produced when hypobromous acid which is an intermediate 

product reacts with the organic substances in a THM precursor. Since bromoform itself is 

structurally stable, bromoform does not react with the organic matters. 

Further, it is considered that since dibromochloromethane, dichloromethane, monobromoacetic 

acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, chloramine 

(monochloroamine, dichloroamine, or trichloroamine), and dibromoacetonitrile have a stable 

chemical structure, they do not react with the organic matters. 

2.4.5 Potential physical effects on wildlife and benthic habitats 

2.4.5.1 Active Substance 

Calcium hypochlorite is hydrolyzed and lost just after it is infused into the water. For this 

reason, it is determined that there is no physical effect on the wildlife or benthic habitats. 

2.4.5.2 Relevant Chemicals 

As the aqueous solubility of bromoform is 0.1 g/100 mL and at a maximum discharge 

concentration of 0.101 mg/L (sections 1.2 and 3.2.3), it is considered that bromoform is 

dissolved in the water. Accordingly, it is determined that the potential physical effect is low. 

Meanwhile, since bromoform has high volatility, some bromoform is diffused to vapour, but 

the diffusion concentration is lower than a background concentration in the atmosphere, 

so that it is determined that the potential and physical effects of bromoform are low. 

It is considered that dibromochloromethane and dichloromethane are volatile and some parts 

of them are distributed from water into air, while halogenated acetic acids, chloramines and 

dibromoacetonitrile have low volatile pressure (less than 1 mmHg) and high water solubility 

(more than 1g/L) and mostly remain in water. Therefore, it is determined that there is no 

physical effect on the wildlife or benthic habitats. 

2.4.5.3 Treated ballast water 

In the ballast water treated by the system, the Relevant Chemicals might be produced, but 

they all have no potential effect on the wildlife or benthic habitats. Furthermore, in the 

BWMS, when FAC in the discharged ballast water is more than 0.2 mg/L, the ballast water is 
MEPC 61/2/6 

Annex, page 29 

I:\MEPC\61\2-6.doc 

neutralized in sodium sulfite and discharged. Therefore, it is determined that the ballast 

water discharged from the BWMS has no potential and physical effect on the wildlife or 

benthic habitats. 

2.4.6 Potential residues in seafood 

2.4.6.1 Active Substance 

As described in section 2.4.1.1, it is considered that calcium hypochlorite is rapidly degraded 

in the water and its half-life is several hours. Further, general consumers' ingestion of 

calcium hypochlorite through the food chain due to residual in see food is not considered due 

the chemical structure. 

2.4.6.2 Relevant Chemicals 

It is determined that all Relevant Chemicals produced in the BWMS are not accumulated in 

the seafood according to solubility in the water and the octanol/water partition coefficient. 

2.4.7 Known interactive in effects 

2.4.7.1 Active Substance 

Calcium hypochlorite is rapidly degraded in the water, but at the same time, THMs, HAAs, 

and HANs are produced by reaction with the organic matters. 

2.4.7.2 Relevant Chemicals 

Bromoform as a comparatively stable chemical is persistent under the aerobic condition, 

while bromoform is bio-degraded in methane bacteria or denitrifying bacteria under the 

anaerobic condition. 

Other Relevant Chemicals are also the comparatively stable chemicals and some of them 

are bio-degraded under the naturalization condition. 

2.5 Physical and chemical properties for the Active Substances and Preparations 

and treated ballast water, if applicable (G9: 4.2.1.4) 

2.5.1 Melting point 

Melting points of Active Substances and Relevant Chemicals are listed in complete dossier. 

2.5.2 Boiling point 

Boiling points of Active Substances and Relevant Chemicals are listed in complete dossier. 

2.5.3 Flammability 

Flammability of Active Substances and Relevant Chemicals is listed in complete dossier. 

2.5.4 Density (relative density) 

Density (relative density) of Active Substances and Relevant Chemicals is listed in complete 

dossier. 
MEPC 61/2/6 

Annex, page 30 

I:\MEPC\61\2-6.doc 

This is the system in which calcium hypochlorite used as the Active Substance infused to 

reach an FAC concentration of 2 mg/L in the ballast water as FAC. Further, calcium 

hypochlorite infused into the ballast water reacts in the water to produce the Relevant 

Chemicals and at the same time, to be rapidly degraded. For this reason, treatment of the 

ballast water by the BWMS does not change the density (relative density) of the treated 

ballast water. 

2.5.5 Vapour pressure, vapour density 

Vapour pressure and vapour density of Active Substances and Relevant Chemicals is listed 

in complete dossier. 

2.5.6 Water solubility/dissociation constant 

Water solubility, dissociation constant of Active Substances and Relevant Chemicals is listed 

in complete dossier. 

2.5.7 Oxidation/reduction potential 

Oxidation/reduction potential of Active Substances and Relevant Chemicals is listed in 

complete dossier. 

Although the oxidation/reduction potential of the treated ballast water is changed by 

existence of calcium hypochlorite, calcium hypochlorite is degraded and reduced as time 

elapses, so that the concentration of the ballast water is restored to a concentration before 

the treatment. 

2.5.8 Corrosivity to the materials or equipment of normal ship construction 

Corrosivity to the materials or equipment of normal ship construction of Active Substances 

and Relevant Chemicals is listed in complete dossier. 

There is a possibility that calcium hypochlorite as the Active Substance and the Relevant 

Chemicals used in this system have corrosivity. It is considered that the treated ballast water 

has no effect on a shipís hull, taking into consideration of a residual concentration of calcium 

hypochlorite and concentrations of produced Relevant Chemicals. Furthermore, according to 

a result of a performed corrosion test, it is assessed that a corrosion effect on coating in the 

ballast tank is negligible. 

2.5.9 Auto-ignition temperature 

Auto-ignition temperature of Active Substances and Relevant Chemicals is listed in complete 

dossier. 

2.5.10 Explosive properties 

Explosive properties of Active Substances and Relevant Chemicals are listed in complete 

dossier. 

2.5.11 Oxidizing properties 

Oxidizing properties of Active Substances and Relevant Chemicals are listed in complete 

dossier. 
MEPC 61/2/6 

Annex, page 31 

I:\MEPC\61\2-6.doc 

2.5.12 Surface tension 

Surface tension of Active Substances and Relevant Chemicals is listed in complete dossier. 

2.5.13 Viscosity 

Viscosity of Active Substances and Relevant Chemicals is listed in complete dossier. 

2.5.14 Thermal stability and identity of relevant breakdown products 

Thermal stability and identity of relevant breakdown products of Active Substances and 

Relevant Chemicals is listed in complete dossier. 

2.5.15 Reactivity toward container material 

There is a possibility that calcium hypochlorite used as the Active Substance basically have 

corrosivity. Accordingly, a material used in a chemical infusion unit adopts SUS316L, PVC, 

and PTFE by considering the corrosivity. 

2.5.16 pH 

A change of pH of the ballast water treated by the BWMS decreases and pH of the treated 

ballast water is restored as time elapses. 

2.5.17 Salinity 

In the BWMS, since calcium hypochlorite is infused into ballasting water, the salinity of the 

treated ballast water is not changed. 

2.5.18 TOC, DOC, % particulate matter 

Calcium hypochlorite used as the Active Substance reacts with the organic matters and 

serves to make them inorganic. Further, when calcium hypochlorite resides with the 

FAC concentration of 0.2 mg/L or more in passing water while it is discharged, calcium 

hypochlorite is neutralized with sodium sulfite and then discharged. Furthermore, this 

system performs filtration treatment. Accordingly, TOC, DOC, and particulate matters in the 

ballast water reduce at discharge. 

2.5.19 Other known relevant physical or chemical hazards 

Other known relevant physical or chemical hazards of Active Substances and Relevant 

Chemicals are listed in complete dossier. 

A safety measure including removal through neutralization with sodium sulfite is performed 

even when the FAC concentration is 0.2 mg/L or more while the treated ballast water is 

discharged, so that there is no concern of physical or chemical hazards. 

2.6 Analytical Methods at Environmentally Relevant Concentration (G9: 4.2.1.5) 

Table 2.6-1 shows a measurement method of calcium hypochlorite used as the Active 

Substance and an analytic method of Relevant Chemicals. 
MEPC 61/2/6 

Annex, page 32 

I:\MEPC\61\2-6.doc 

Table 2.6-1: Analytical methods at environmentally relevant concentrations 

of Active Substances and Relevant Chemicals 

Chemical name Method Applicability Sensitivity 

Reference/ 

Comments/ 

Justification for 

missing data 

Calcium 

hypochlorite 

(FAC) 

DPD 

absorptionmetric 

method 

In liquids 0.01 mg/L Water test method*

Bromoform 

PT-GC/MS method 

or HS-GC/MS 

method 

In liquids 0.0001 mg/L Water test method*

Dibromochloromethane 

PT-GC/MS method 

or HS-GC/MS 

method 

In liquids 0.0001 mg/L Water test method*

Dichloromethane 

PT-GC/MS method 

or HS-GC/MS 

method 

In liquids 0.0001 mg/L Water test method*

Monobromoacetic acid 

Solvent extraction ñ 

derivatization ñ gas 

chromatographicmass spectrometric 

assay 

In liquids 0.0001 mg/L 

Notification No.261 

of 2003 Ministry of 

Health, Labour and 

Welfare 

Dibromoacetic 

acid 

Solvent extraction ñ 

derivatization ñ gas 

chromatographicmass spectrometric 

assay 

In liquids 0.0001 mg/L 

Notification No.261 

of 2003 Ministry of 

Health, Labour and 

Welfare 

Tribromoacetic 

acid 

Solvent extraction ñ 

derivatization ñ gas 

chromatographicmass spectrometric 

assay 

In liquids 0.0001 mg/L 

Notification No.261 

of 2003 Ministry of 

Health, Labour and 

Welfare 

Dibromochloroacetic 

acid 

Solvent extraction ñ 

derivatization ñ gas 

chromatographicmass spectrometric 

assay 

In liquids 0.0001 mg/L 

Notification No.261 

of 2003 Ministry of 

Health, Labour and 

Welfare 

Chloramine 

DPD 

absorptiometric 

method 

In liquids 0.01 mgL Water test method*

Dibromoacetonitrile 

Gas 

chromatographicmass spectrometric 

assay 

In liquids 0.001 mg/L Water test method*

*

 Water analysis manual published by Japan Water Works Association.

3 USE OF THE ACTIVE SUBSTANCE 

3.1 Outline of Kuraray Ballast Water Management System 

The BWMS consists of a combination of a filtration and a disinfection processes. 
MEPC 61/2/6 

Annex, page 33 

I:\MEPC\61\2-6.doc 

3.1.1 Filtration process

The filtration process of the BWMS includes a filtration unit, which removes sediment 

particles. Following an automated program, the filtration unit regularly performs 

back-flushing by which long-term operation is possible free of filter clogging. By the 

back-flushing process, sediment, aqueous microorganisms, etc., that are caught on the filters 

are returned to the sea area from which the ballast water was drawn. 

3.1.2 Disinfection process 

Following filtration, the water is treated by the disinfection process that infuses the Active 

Substance. Active Substance used in the BWMS is KURARAY AS that contains calcium 

hypochlorite as the main component. 

3.1.3 Disinfection component

Hypochloric acid is called free active chlorine (FAC) and has a strong disinfection effect. The 

BWMS treats seawater using an FAC concentration of 2 mg/L. FAC is often used as a 

disinfectant in the field of water treatment. FAC is added to drinking water or pools in many 

countries, therefore its safety has been confirmed. 

Thus it is an advantage that the BWMS uses FAC to disinfect microorganisms in seawater. 

The seawater treated by the BWMS including the filtration process and the disinfection 

process satisfies the regulation D-2 of the BWM Convention. 

3.2 The manner of application (G9: 4.2.6 and 7) 

3.2.1 Maximum dosage concentration of KURARAY AS 

Calcium hypochlorite is infused so that its concentration at the time of the infusion into the 

ballast water becomes 2 mg/L as FAC. The infusion dose of calcium hypochlorite is 

automatically controlled in proportion to the flow rate of the ballast water to maintain the 

FAC concentration at 2 mg/L. 

3.2.2 Holding time 

The holding time in the ballast tank after the treatment is not set. The reason is that when the 

FAC concentration in the discharged ballast water exceeds 0.2 mg/L, the FAC concentration 

is adjusted to 0.2 mg/L or less by the neutralization process prior to being discharged. 

3.2.3 The maximum allowable discharge concentrations of the Relevant Chemicals 

The concentration of the FAC and the Relevant Chemicals that are included in the treated 

water are measured in accordance with the toxicity test described in sections 6.2 and 6.3 of 

the basic assessment report. In the toxicity test, the treated water with calcium hypochlorite 

(added to a FAC concentration of 2 mg/L) is diluted to 10 v/v% Therefore, the maximum 

allowable discharge concentrations of the Relevant Chemicals (listed below) are at present 

ten times higher than the concentrations measured by the toxicity test (at 10 v/v%. In addition, 

as described above, calcium hypochlorite (the Active Substance) becomes 0.2 mg/L 

(as FAC) or less by the time of deballast, and the maximum allowable discharge 

concentration of FAC is 0.2 mg/L. See below: 
MEPC 61/2/6 

Annex, page 34 

I:\MEPC\61\2-6.doc 

Calcium hypochlorite (FAC): 0.2mg/L 

Bromoform: 0.101 mg/L 

Dibromochloromethane: 0.002 mg/L 

Dichloromethane: 0.062 mg/L 

Monobromoacetic acid: 0.003 mg/L 

Dibromoacetic acid: 0.04 mg/L 

Tribromoacetic acid: 0.05 mg/L 

Dibromochloroacetic acid: 0.03 mg/L 

Monochloroamine: 0.2 mg/L (as chloromines) 

Dichloroamine: 0.2 mg/L (as chloromines) 

Trichloroamine: 0.2 mg/L (as chloromines) 

Dibromoacetonitrile: 0.02 mg/L

3.2.4 Handling, use, storage and transport of the chemicals 

3.2.4.1 Calcium hypochlorite 

3.2.4.1.1 Handling 

At the time of handling, a worker wears goggle-type protective glasses, a dust respirator, and 

protective gloves made of rubber in addition to protective clothing such as long sleeves and 

long pants. 

3.2.4.1.2 Storage and transport 

Storage and transporting according to the recommendation of P & I International Group for 

transportation by ship (November 11, 1999, and November, 2000) are handled as follows: 

.1 Avoid direct sunlight and maintain separation from residential areas. 

Transport in a drum and limit the packaging unit net weight to a maximum 

of 45 kg; 

.2 If the external temperature exceeds 35°C, stored in a place where there are 

ventilation facilities; and 

.3 Do not mix chlorinated isocyanuric acid (organic bleaching powder), 

reducing chemicals, flammable chemicals and acids. 

3.2.4.1.3 Use 

Calcium hypochlorite is stored as a powder and dissolved in seawater immediately before 

infusion. Thereafter, calcium hypochlorite is infused into the ballast pipe so that the 

FAC concentration becomes 2 mg/L. 
MEPC 61/2/6 

Annex, page 35 

I:\MEPC\61\2-6.doc 

3.2.4.2 Sodium sulfite 

3.2.4.2.1 Handling 

At the time of handling, a worker wears goggle-type protective glasses, a dust respirator, and 

protective gloves made of rubber in addition to protective clothing such as long sleeves and 

long pants.

3.2.4.2.2 Storage and transport 

A well-ventilated dry place shall be used for storage and direct sunlight must be avoided 

during transport and storage. 

3.2.4.2.3 Use 

Sodium sulfite is stored as a powder and is dissolved at the time of deballast. When the 

residual FAC concentration exceeds 0.2 mg/L at the time of deballast, the sodium sulfite is 

automatically infused into the deballast line. 

3.2.5 Procedures and use of the system 

At the time of filling ballast water, seawater is fed from the sea chest by operation of the 

ballast pumps to the filtration unit to remove sediments and larger planktons. Then in the 

chemical infusion unit Active Substance (calcium hypochlorite) is infused into the ballast line 

at a FAC conccentration of 2 mg/L. 

At the time of deballasting, the residual FAC concentration is monitored by chlorine 

meters. When the residual FAC concentration is 0.2 mg/L or less, the discharge is 

performed as it is. 

The residual FAC concentration is confirmed again just before being discharged. 

When the residual FAC concentration is higher than 0.2 mg/L, the neutralization process 

is operated. In chemical infusion unit, sodium sulfite is infused into the deballast line. 

The FAC concentration is monitored again to be 0.2 mg/L or less just before being 

discharged. 

3.2.6 Risk management measures in case of emergency 

Generally, fire is one major problem considered on a ship. The risk is avoided by performing 

the following measures in case of fire. 

When fire occurs in compartments in which calcium hypochlorite is stored, since there is a 

possibility of generating toxic gas such as chlorine, the protective equipment for fire 

extinction including self-contained respirator is prepared. The chemicals and the 

circumference thereof are water-sprinkled with a large amount of seawater and then cooled. 

When fire occurs in compartments in which the sodium sulfite is stored, since there is a 

possibility of generating toxic gas such as sulfur oxide, etc., protective equipment including 

self-contained respirators are made available. The powder fire extinguisher is used for fire 

extinction. 

In the case of any circumference fire, the chemical is rapidly moved to a separate place.
MEPC 61/2/6 

Annex, page 36 

I:\MEPC\61\2-6.doc 

3.2.7 Other safety measures 

Chemicals are stored appropriately. Opening and closing procedure of the valves of the 

filtration unit is conducted with safety measures to avoid malfunction.

When abnormalities in flow rate, pressure, etc., are detected, the alarm is issued 

immediately and the entire system automatically performs an emergency stop. 

Furthermore, when the emergency stop button of each device is pressed on the site, the 

entire system is shutdown.

Control of the BWMS is performed in the main control unit and various kinds of abnormal 

information are displayed on the main control unit. When an abnormality occurs, two kinds of 

signals, alarm and warning, can be generated. In the case of a warning, the yellow lamp of 

the main control unit is lighted and the abnormal conditions are displayed. In the case of the 

alarm, the red lamp of the main control unit is lighted and the abnormal conditions are 

displayed and the system immediately stops. 

In the BWMS, when an alarm is issued, since the entire system stops immediately, 

which affects the ballast loading and unloading on the ship, adequate treatment is 

performed when a warning is issued. 

3.2.8 Control of discharged water 

When the residual FAC concentration in the discharged ballast exceeds 0.2 mg/L, it is 

automatically neutralized by the sodium sulfite. When the residual FAC concentration 

is 0.2 mg/L or less, it is discharged as it is. 

3.2.9 Control of the waste and recycling 

In the filtration process, the sediment and the aqueous micro-organisms, and the like, 

which are generated by backflushing the filter, are discharged to the sea area where the 

ballast was originally drawn. 

When signal that shows the lifespan of the filter is coming to the end is on, the ballast 

treatment is stopped and the filter exchange is immediately performed. The exchanged and 

used filter is incinerated on land or on a ship according to general waste treatment methods. 

4 MATERIAL SAFETY DATA SHEETS 

MSDS relating to each of Kuraray AS, which is an Active Substance and Kuraray NS, which 

is a neutralizer is shown in appendix 1 of the complete dossier. 

5 RISK CHARACTERIZATION 

5.1 Screening for Persistence, Bioaccumulation and Toxicity (G9: 5.1) 

5.1.1 Persistence (G9: 5.1.1.1) 

Since calcium hypochlorite, which is an Active Substance, has a very short half-life in water 

as described in section 2.4.1.1 of this Basic Assessment Report, it has no persistence. 

Meanwhile, in the case of the Relevant Chemicals, as described in section 2.4.3 of this Basic 

Assessment Report, chloramines among nine chemicals has no persistence, while eight 

substances including bromoform, dibromochloromethane, dichloromethane, monobromoacetic 

acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, and dibromoacetonitrile 

have persistence. 
MEPC 61/2/6 

Annex, page 37 

I:\MEPC\61\2-6.doc 

5.1.2 Bioaccumulation (G9: 5.1.1.2) 

Calcium hypochlorite, which is an Active Substance, does not cause the bioaccumulation 

due to high water solubility and reactivity as described in section 2.4.2.1 of this Basic 

Assessment Report. 

Further, none of the nine Relevant Chemicals causes the bioaccumulation from their 

water-octanol partition coefficient and BCF. 

5.1.3 Toxicity test (G9: 5.1.2.3) 

The toxicity is determined using a chronic toxicity value of NOEC < 0.01 mg/L. Since calcium 

hypochlorite, which is an Active Substance, has the NOEC of 0.005 mg TRC/L, it has toxicity. 

However, among the Relevant Chemicals, since bromoform, dibromochloromethane, 

dichloromethane, monobromoacetic acid have NOEC of more than 0.01 mg/L, they have no 

toxicity. 

Meanwhile, no chronic toxicity test value can be found in respect to five chemicals including 

dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, chloramines, and 

dibromoacetonitrile. As a result, these five chemicals are treated to have toxicity. 

(see section 2.2.2) 

5.1.4 Do the KURARAY AS and Relevant Chemicals meet all three criteria for PBT? 

From the above-mentioned result, the PBT of the Active Substances and Relevant 

Chemicals is shown as Table 5.1-1. The Active Substances and the Relevant Chemicals of 

the BWMS do not correspond to the PBT substances. 

Table 5.1-1: PBT of Active Substances and Relevant Chemicals 

 Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n)

PBT criteria 

Half-life: 

> 60 days in 

marine water, or 

> 40 days in 

freshwater,* or 

> 180 days in 

marine 

sediments, or 

> 120 days in 

freshwater 

sediments 

Experimentally 

determined BCF 

> 2,000, or if no 

experimentally BCF has 

been determined, 

log Pow; 3

Chronic 

NOEC 

< 0.01 mg/L Reference/ 

Comments/ 

Justification 

for missing 

data

Calcium hypochlorite N N Y 

Bromoform Y N N 

Dibromochloromethane Y N N 

Dichloromethane Y N N 

Monobromoacetic acid Y N N 

Dibromoacetic acid Y N Y 

Tribromoacetic acid Y N Y 

Dibromochloroacetic acid Y N Y 

Chloramine N N Y 

Dibromoacetonitrile Y N Y 

5.1.1-5.1.3 
MEPC 61/2/6 

Annex, page 38 

I:\MEPC\61\2-6.doc 

6 EVALUATION OF THE TREATED BALLAST WATER 

6.1 Test of the treated ballast water for the Basic Approval 

6.1.1 Outline of the tests 

The performed tests are acute and chronic toxicity tests on aquatic organisms, a corrosion 

test, and a degradation test of FAC. 

6.1.2 Test equipment 

The test equipment consists of prototype land-based test equipment having a treatment flow 

rate of 960 L/h as shown in Figure 6.1-1. 

Figure 6.1-1: Schematic diagram of small-scale set-up for Kuraray 

Ballast Water Management System 

6.1.3 Quality control 

Of the tests performed, the toxicity tests (acute and chronic toxicity tests) on aquatic 

organisms were conducted in accordance with "OECD Principles of Good Laboratory 

Practice (GLP)" (1997) under the quality control Institute of Environmental Ecology, IDEA 

Consultants, Inc., which has ISO/IEC 17025 (JIS Q 17025) accreditation. 

The corrosion test was performed by the National Maritime Research Institute, based on 

ISO 9001 of Laboratory of Aquatic Science Consultant Co., Ltd. and QAPP conform to 

ISO/IEC 17025. 

The degradation test was performed by Kuraray Co., Ltd., independently. 
MEPC 61/2/6 

Annex, page 39 

I:\MEPC\61\2-6.doc 

6.2 Acute toxicity test (G9: 5.2.2) 

The test was performed in accordance with Guidelines (G8) for the seawater and brackish 

water conditions. 

The test consists of following three parts; a growth inhibition test on algae Skeletonema 

costatum, an acute toxicity test on gammaridea Hyale barbicornis and an acute toxicity test 

on fish Oryzias javanicus. These aquatic organisms are all marine species. 

The results of acute toxicity test on ballast water were summarized in Table 6.2-1. 

In accordance with Guidelines (G8) for land-based testing, the test under brackish water 

conditions showed the most sensitive effect on the algae, Skeletonema costatum, in which 

ErC50 was calculated as 5.8% dilution. FAC in the exposed water was less than 0.01 mg/L. 

In addition, under brackish water conditions, the growth inhibition on the algae, Skeletonema 

costatum was observed in the neutralization group where test water was neutralized by 

adding 2.0 mg/L of sodium sulfite to 33% (v/v)-diluted TWD. 

The growth inhibition is considered to be attributed to the chloramines (bonded chlorine). 

This effect, however, lasts very short as chloramines degrades quite rapidly. We will conduct 

necessary tests to confirm the chloramines effect and degradation for Final Approval. 

No toxic effects on crustacea and fish were observed in 10% diluted-TWD and 

neutralized-TWD groups. 

Table 6.2-1: LC50 and ECr50 and maximum concentration of Active Substance (FAC) 

upon exposure in toxicity test of ballast water treated 

by prototype test equipment 

Test 

water 

Max. concentration 

of FAC (mg/L) 

Fish: 

Oryzias 

javanicus 

(96h-LC50) 

Crustacea:

Hyale 

barbicornis 

(96h-LC50) 

Algae: 

Skeletonema 

costatum 

(72h-ErC50) 

Algae 

Skeletonema 

costatum 

0.01mg/L 

Crustacea 

Hyale 

barbicornis 

0.01mg/L 

Seawater 

Fish 

Oryzias 

javanicus 

0.02mg/L 

> 10% > 10% > 10% 

Algae 

Skeletonema 

costatum 

<0.01mg/

L 

Crustacea 

Hyale 

barbicornis 

<0.01mg/

L Brackish 

Water 

Fish 

Oryzias 

javanicus 

0.02mg/L 

> 10% > 10% 5.8% 

* In the Table, acute toxicity values were expressed as dilution rate of discharged ballast 

water. Maximum concentration of chloramines on algae test was 0.02 mg/L (10% dilution).
MEPC 61/2/6 

Annex, page 40 

I:\MEPC\61\2-6.doc 

6.3 Chronic toxicity test (G9: 5.2.1) 

The test was performed in accordance with Guidelines (G8) for the seawater and brackish 

water conditions. 

The test consists of following three parts; a growth inhibition test on algae Skeletonema 

costatum (same test performed in acute toxicity test), a chronic toxicity test on gammaridea 

Hyale barbicornis and a chronic toxicity test on fish Oryzias javanicus. These aquatic 

organisms are all marine species. 

The results of chronic toxicity test on ballast water, which was treated by the prototype test 

equipment of the BWMS, were summarized in Table 6.3-1. The acute toxicity test on growth 

inhibition of algae stated in section 6.2 can also be a chronic toxicity test as life cycle of algae 

is short time. 

According to the results of the chronic toxicity test, it showed the most sensitive effect on the 

algae, Skeletonema costatum, and 72h-NOEC was calculated as 0.4% dilution. FAC in the 

exposed water was less than 0.01 mg/L. In addition, under brackish water conditions, the growth 

inhibition on the algae, Skeletonema costatum was observed in the neutralization group, where 

test water was neutralized by adding 2.0 mg/L of sodium sulfite to 33% (v/v)-diluted TWD. 

The growth inhibition is considered to be attributed to the chloramines (bonded chlorine) as 

stated in section 6.2. This effect, however, lasted very short as chloramines degraded quite 

rapidly. We will conduct necessary tests to confirm the chloramines effect and degradation 

for Final Approval. 

No toxic effects on crustacea and fish were observed in 10% diluted-TWD and 

neutralized-TWD groups. 

Table 6.3-1: NOEC and maximum concentration of Active Substance (FAC) 

upon exposure in toxicity test of ballast water treated 

by prototype test equipment 

Test water 

Max. concentration of FAC in 

No Observed Effect Test Water 

Case (mg/L) 

Fish: 

Oryzias 

javanicus 

(28day-NOEC) 

Crustacea: 

Hyale 

barbicornis 

(21day-NOEC) 

Algae: 

Skeletonema 

costatum 

(72h-NOEC) 

Algae 

Skeletonema 

costatum 

<0.01mg/L 

Crustacea 

Hyale barbicornis 

Seawater 0.02mg/L 

Fish 

Oryzias javanicus 

0.02mg/L 

10% 10% 2% 

Algae 

Skeletonema 

costatum 

<0.01mg/L 

Crustacea 

Hyale barbicornis 

0.02mg/L Brackish 

water 

Fish 

Oryzias javanicus 

0.02mg/L 

10% 10% 0.4% 

* In Table, chronic toxicity (NOEC) was expressed as a ratio of discharged ballast water to test 

water. Maximum concentration of chloramines on algae test was 0.02 mg/L (10% dilution). 
MEPC 61/2/6 

Annex, page 41 

I:\MEPC\61\2-6.doc 

6.4 Corrosion test 

The influence of calcium hypochlorite (Kuraray AS) used in the ballast water management 

system that is under development by KURARAY CO., LTD. on coating degradation under the 

environment of seawater and brackish water is investigated, and the results are used as the 

basic application data for Basic Approval. Here, the evaluation is carried out on the safer 

side by setting the concentration of the added calcium hypochlorite at a concentration 

(free active chlorine, FAC, concentration: 3 mg/L) higher than the charged concentration 

(FAC concentration: 2 mg/L) in the operation of Kuraray Ballast Water Management System. 

It has been clarified that the influence of an Active Substance on ballast tank coating in the 

ballast water management system is limited even in the light of acceptance criteria of PSPC 

and that the influence thereof on the ballast tank protection performance and a service life is 

negligible. 

6.5 Mode of Degradation 

Degradation of FAC concentration in the system is determined. Calcium hypochlorite was 

infused into the system in the toxicity test to adjust the concentration of FAC to 2 mg/L and 

the FAC concentrations were measured for up to 120 hours by DPD method. Test water was 

adjusted in accordance with Guidelines (G8) for the seawater and brackish water conditions, 

and then passed through the filtration unit of the system. The water was stored in a dark 

room at four kinds of temperatures, 5, 10, 20 and 30°C. 

The results under seawater and brackish water conditions are shown in Figures 6.5-1 

and 6.5-2, respectively. 

Degradation rate was generally higher in the brackish water and lower in the seawater. 

The degradation rate was higher at a higher temperature. 

At 5°C under the seawater condition it had the lowest degradation rate. Even though a 

half-life, at which the concentration decreases from 2 mg/L upon infusion to 1 mg/L, was 

about 15 minutes, which is fast enough. 

From the test results, it was suggested that the neutralization with sodium sulfite, which is 

operated when concentration of FAC is more than 0.2 mg/L, will be performed only in the 

case when deballasting is operated in a short period of time at a lower temperature. 

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

2.0

0 20 40 60 80 100 120

Elapsed tim e hr

FAC conc. mg/L

30°C

20°C

10°C

5°C

Figure 6.5-1: Time-dependent change of FAC concentration of treated ballast water 

under seawater conditions 
MEPC 61/2/6 

Annex, page 42 

I:\MEPC\61\2-6.doc 

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

2.0

0 20 40 60 80 100 120

Elapsed time

FAC conc.

mg

30°C

20°C

10°C

5°C

Figure 6.5-2: Time-dependent change of FAC concentration of treated ballast water 

under brackish water conditions 

6.6 Determination of holding time 

In the system, the holding time of the ballast tank is not specified. 

6.7 Risk characterization and analysis 

6.7.1 Reaction with organic matter (G9: 4.2.1.3) 

In order to examine the reaction between organic materials and calcium hypochlorite infused 

into the system, the concentrations of various chemicals were analysed using the toxicity test 

on aquatic organism. The results are shown in Table 2.1-2. Consequently, production of the 

following chemicals was confirmed, and they were considered relevant for risk assessment: 

.1 bromoform, 

.2 dibromochloromethane, 

.3 dichloromethane, 

.4 monobromoacetic acid, 

.5 dibromoacetic acid, 

.6 tribromoacetic acid, 

.7 dibromochloroacetic acid, 

.8 chloramines (monochloroamine, dichloroamine or trichloroamine), and 

.9 dibromoacetonitrile. 

6.7.2 Characterization of degradation route and rate (G9: 5.3.5) 

Details about the decomposition of Active Substances and Relevant Chemicals in biotic and 

abiotic environments are described in section 2.4.1. 
MEPC 61/2/6 

Annex, page 43 

I:\MEPC\61\2-6.doc 

In the BWMS, where the concentration of FAC is more than 0.2 mg/L upon deballasting, 

neutralization with sodium sulfite is to be performed to reduce the concentration to 0.2 mg/L 

or lower prior to discharge. 

6.8 Prediction of Discharge and Environmental Concentrations 

Prediction Environmental Concentration (PEC) of calcium hypochlorite and the Relevant 

Chemicals that were contained in ballast water discharged from the BWMS was calculated 

by using the MAMPEC model ver. 2.0 as applied to the Port of Tokyo. 

Maximum discharge concentration of FAC is 0.2 mg/L. Maximum allowable discharge 

concentration of Relevant Chemicals are described in section 3.2.3. Table 6.8-1 show 

calculated PEC of each chemical. 

Table 6.8-1(1): Calculation results of PEC using the MAMPEC model ver. 2.0 

for the designated sea area 

PEC of calcium hypochlorite 

(FAC: μg/ L) 

Maximum concentration 0.020 

95% concentration 0.0203 

Average concentration 0.0129 

Median concentration 0.0127 

Minimum concentration 0.00278 

Table 6.8-1(2): Calculation results of PEC using the MAMPEC model ver. 2.0 

for the designated sea area 

PEC of Relevant Chemicals (μg/L) 

Bromoform Dibromochloromethane Dichloromethane 

Maximum concentration 0.0114 0.000199 0.00512 

95% concentration 0.0105 0.000182 0.00479 

Average concentration 0.00668 0.000115 0.00290 

Median concentration 0.00663 0.000114 0.00278 

Minimum concentration 0.00145 0.0000247 0.000614 

Table 6.8-1(3): Calculation results of PEC using the MAMPEC model ver. 2.0 

for the designated sea area 

PEC of Relevant Chemicals (μg/L) 

Monobromoacetic 

acid 

Dibromoacetic 

acid 

Tribromoacetic 

acid 

Maximum concentration 0.000348 0.00468 0.00591 

95% concentration 0.000322 0.00433 0.00546 

Average concentration 0.000204 0.00275 0.00348 

Median concentration 0.000204 0.00275 0.00349 

Minimum concentration 0.0000443 0.000596 0.000753 
MEPC 61/2/6 

Annex, page 44 

I:\MEPC\61\2-6.doc 

Table 6.8-1(4): Calculation results of PEC using the MAMPEC model ver. 2.0 

for the designated sea area 

PEC of Relevant Chemicals (μg/L) 

Dibromochloroacetic acid 

Chloramines 

(as Monochloroamine) 

Dibromoacetonitrile 

Maximum concentration 0.00354 0.0214 0.00181 

95% concentration 0.00328 0.0197 0.00168 

Average concentration 0.00209 0.0125 0.00104 

Median concentration 0.00209 0.0125 0.00101 

Minimum concentration 0.000452 0.00269 0.000222 

6.9 Assessment of potential for bioaccumulation 

Referring to section 2.4.2, the log Pow values of FAC and the Relevant Chemicals 

discharged from the BWMS are considered to fall below the log Pow of 3, which indicates the 

chemicals are not prone to bioaccumulation. Therefore, there is no risk of bioaccumulation 

due to FAC and the Relevant Chemicals discharged from the BWMS. 

6.10 Effects assessment 

Maximum concentration of calcium hypochlorite as FAC estimated to be 0.2 mg/L when 

discharging ballast water without sodium sulfite neutralization. This value exceeds the acute 

toxicity 0.005 mg/L (LC50 for 24 h) and chronic toxicity 0.005 mg TRC/L (NOEC for 133d). 

Maximum concentration of chloramines also estimated to be 0.2 mg/L when discharging 

ballast water without sodium sulfite neutralization. This value exceeds most of the acute 

toxicity such as 0.001 mg/L (EC50 for 48 h) for clam. Therefore general assessment of 

effects of discharged ballast water in the system should be focused on calcium hypochlorite 

(FAC) and chloramines. 

According to PEC values estimated in section 6.8, average concentration of calcium 

hypochlorite (FAC: 0.0129 μg/L) and chloramines (0.0125 μg/L) are higher than other 

Relevant Chemicals. 

When sodium sulfite neutralization is performed at discharge, on the other hand, maximum 

discharge concentration reduced to be 0.02 mg/L for the two chemicals. Therefore risk on 

discharged ballast water with neutralization expected to be allowable. 

Both FAC and chloramines degrade rapidly. Chloramines degrade very rapidly after 

hydrolysis. Analysis at toxicity test was conducted soon after the treatment or neutralization. 

In actual operation of the BWMS on ship it is considered that FAC and chloramines are at quite 

low concentration. Therefore risk on discharged ballast water, in actual operation on ship or 

after neutralization conducted when FAC exceeds 0.2 mg/L, expected to be allowable. 

For other Relevant Chemicals there is hardly any risk, because the maximum concentration 

of other Relevant Chemicals discharged from the BWMS do not exceed acute toxicity and 

chronic toxicity values. Moreover, with reference to section 6.9 when the properties of the 

discharged FAC and Relevant Chemicals are first considered, bioaccumulation is unlikely to 

occur, and any toxic effects resulting from accumulation through the food web are also 

unlikely to take place. 
MEPC 61/2/6 

Annex, page 45 

I:\MEPC\61\2-6.doc 

6.11 Effects on aquatic organisms 

6.11.1 Estimation of PNEC 

The PNEC of the Active Substance and Relevant Chemicals discharged from the BWMS is 

determined as follows. With regard to tribromoacetic acid and dibromochloroacetic acid of 

the Relevant Chemicals, there are no data of toxicity test on aquatic organisms, and 

therefore, they are excluded for the determination of PNEC. 

 .1 Calcium hypochlorite (FAC) 

PNEC short 0.5μg/L (Assessment Factor (AF) =10) 

LC50 and EC50 are obtained from many marine and fresh water species 

(total 34) and the lowest is 0.005 mg/L (LC50). 

PNEC long 0.5μg/L (AF =10) 

NOEC is obtained from marine and fresh water species (4 each) and the 

lowest is 0.005 mg/L (NOEC). 

.2 Bromoform: 

PNEC short 710μg/L (AF =10) 

LC50 and EC50 are obtained from 12 species and the lowest is 7.1 mg/L (LC50). 

PNEC long 96μg/L (AF =50) 

NOEC is obtained from 2 fresh water species and the lowest is 4.8 mg/L 

(NOEC). 

.3 Dibromochloromethane: 

PNEC short 96μg/L (AF =100) 

LC50 and EC50 are obtained from 3 fresh water species and the lowest 

is 9.6 mg/L (EC50). 

PNEC long 0.63μg/L (AF =100) 

NOEC is obtained from 2 fresh water species and the lowest is 0.063 mg/L 

(NOEC). 

.4 Dichloromethane: 

PNEC short 9700μg/L (AF =10) 

LC50 and EC50 are obtained from 6 fresh water species and 3 marine 

species and the lowest is 97.0 mg/L (LC50). 

 PNEC long 82.5μg/L (AF =1000) 

NOEC is obtained from a fresh water fish and is 82.5 mg/L (NOEC). 

.5 Monobromoacetic acid: 

PNEC short 14μg/L (AF =100) 

EC50 is obtained from 2 species and the lowest is 1.4 mg/L (EC50). 

PNEC long 0.14μg/L (AF =10000) 

NOEC of 1.6 mg/L is obtained but from a non-sensitive species and EC50 is 

applied as chronic index. 
MEPC 61/2/6 

Annex, page 46 

I:\MEPC\61\2-6.doc 

.6 Dibromoacetic acid: 

PNEC short 69μg/L (AF =1000) 

PNEC long 6.9μg/L (AF =10000) 

LC50 is obtained from one species and is 69 mg/L (LC50). 

.7 Chloramines: 

PNEC short 0.01μg/L (AF =100) 

LC50 and EC50 are obtained from marine and fresh water species (3 each) 

and the lowest is 0.001 mg/L (EC50) 

PNEC long: Not evaluated (rapidly degrade after hydrolysis). 

.8 Dibromoacetonitrile: 

PNEC short 0.55μg/L (AF =1000) 

PNEC long 0.055μg/L (AF =10000) 

LC50 is obtained from one fresh water species and is 0.55 mg/L (LC50). 

6.11.2 Ratio PEC/PNEC 

On the basis of the PEC calculated in section 6.8.4 and the PNEC assumed in 

section 6.11.1, PEC/PNEC was calculated and the results are shown in Table 6.11-1. 

PEC/PNEC of the Active Substance and Relevant Chemicals, except for chloramines, 

discharged from the BWMS falls far below one. As stated in section 6.10, general 

assessment of effects of discharged ballast water in the system should be focused on 

calcium hypochlorite (FAC) and chloramines. For FAC, PEC/PNEC is no problem even at 

the maximum discharged concentration of 0.2 mg/L without neutralization. 

For chloramines, however, the PEC/PNEC (short) ratio exceeds one. Chloramines have 

good resolvability and expected to degrade easily while stored in ballast tanks and after 

discharge. The result shows that there is a possibility to show some effect on surrounding 

marine environment when discharged soon after ballasting and without neutralization. 

In this respect, PEC is calculated for chloramines in the case that sodium sulfite 

neutralization is performed. The discharged concentration is 0.02 mg/L, which is the 

maximum concentration detected. Average PEC is 0.00125 μg/L and PNEC short 

is 0.01 μg/L. PEC/PNEC short is 0.125 falling short of one. 

Thus with neutralization process, risk to the environment is considered allowable. In actual 

operation of the BWMS on ship, ballast water is not discharged soon after the treatment. 

Taking into account the mode of degradation of chloramines, risk to the environment is also 

considered allowable. We will conduct necessary tests to confirm degradation of 

chloramines and evaluate the risk to the environment for Final Approval. 
MEPC 61/2/6 

Annex, page 47 

I:\MEPC\61\2-6.doc 

Table 6.11-1: PEC, PNEC and PEC/PNEC ratio 

PNEC (μg/L) PEC/PNEC Relevant Chemicals PEC 

(μg/L) long short long short 

Calcium hypochlorite (FAC) 0.0129 0.5 0.5 0.0258 0.0258 

Bromoform 0.00668 96 710 0.0000695 0.0000094

Dibromochloromethane 0.000115 0.63 96 0.0001825 0.0000011

Dichloromethane 0.0029 82.5 9700 0.0000351 0.0000002

Monobromoacetic acid 0.000204 0.14 14 0.0014571 0.0000145

Dibromoacetic acid 0.00275 6.9 69 0.0003985 0.0000398

Chloramines 0.0125 --- * 0.01 --- * 1.25 

Dibromoacetonitrile 0.00104 0.055 0.55 0.018909 0.0018909

* PNEC long for chloramines is not evaluated because chloramines are very rapidly degraded 

by hydrolysis (see section 2.4.1.2). 

6.12 Effects on sediment 

As described in section 2.2.4, calcium hypochlorite and the Relevant Chemicals discharged 

from the system are unlikely to cause adhesion or accumulation in the sediment. Therefore, 

it is considered that there are no effects on sediment. 

6.13 Comparison of general assessment of effects with discharge toxicity 

Assessment of the treated ballast water summarized in section 6 shows there is a worry to 

have effect on marine environment because of the toxicity of chloramines when calcium 

hypochlorite (Active Substance) is infused into ballast tanks and discharged in a short time 

without neutralization. However, in most cases there seems to be no problem considering 

that chloramines degrade rapidly while stored in ballast tanks in practical ship navigation. 

The BWMS is the system that when ballast water is discharged in a short time after 

ballasting, the FAC concentration is monitored and sodium sulfite neutralization is conducted 

if necessary. Even if chloramines remained in the discharged water, the maximum 

concentration is confirmed to be 0.02 mg/L with neutralization and PEC/PNEC ratio is less 

than 1 and risk is considered to be allowable. 

The result of general assessment on effects is nearly identical to the test result that slight 

acute and chronic toxicity effects (ECr50 is 5.8% dilution and NOEC is 0.4% on algae) have 

been observed in the toxicity tests of treated ballast water discharged from the system on 

aquatic organisms. The result is also nearly identical to the test results that growth inhibition 

is observed on algae at neutralization group (see appendix 2). 

7 RISK ASSESSMENT 

7.1 Risk to safety of ship 

7.1.1 Increased corrosion 

As described in section 6.4 "Corrosion test" of this Basic Assessment Report, the corrosion 

effect of ballast water treated by the system on coating in a ballast tank is not considered. 

Further, it is determined that the effect of corrosive force on such a level on other materials 

configuring ships is also within tolerance. Accordingly, it is considered not to have a 

corrosion effect. 
MEPC 61/2/6 

Annex, page 48 

I:\MEPC\61\2-6.doc 

7.1.2 Fire and explosion 

In the BWMS, calcium hypochlorite is used as the Active Substance. Calcium hypochlorite 

does not cause self-combustion, but when it contacts other substances, it may generate 

heat. Accordingly, it is stored in a container that ensures complete isolation. 

7.1.3 Storage and handling of the substances 

The safety of the storage of calcium hypochlorite is ensured according to a recommendation 

(November, 1999 and November, 2000) of the P&I International Group for transportation by 

ship, as described in section 3.2.4.1.2 of this Basic Assessment Report. Further, in a 

well-ventilated dry place, calcium hypochlorite is stored while avoiding direct sunlight, 

thereby ensuring the safety.

7.1.4 Contact with, or inhalation of, process products 

As described in section 2.3.2.1 of this Basic Assessment Report, calcium hypochlorite has 

irritation and when calcium hypochlorite is inhaled or contacts a skin, histological changes 

may occur. 

Furthermore, sodium sulfite as a neutralizer has almost no irritation. As a countermeasure 

thereof, as described in section 3.2.4 of this Basic Assessment Report, workers wear 

goggle-type protective glasses, a dust respirator, protective gloves made of rubber, and 

protective clothing such as long sleeves and long pants, thereby ensuring the safety in 

handling calcium hypochlorite. Even when handling sodium sulfite used as neutralizer, the 

workers wear goggle-type protective glasses, the dust respirator, the protective gloves made 

of rubber, and the protective clothing such as long sleeves and long pants.

7.1.5 Noise 

In operating the system, noise is not generated. 

7.2 Risk to human health 

7.2.1 Health effects to humans (G9: 5.3.1.2) 

An acute toxicity value of calcium hypochlorite which is an Active Substance 

is LD50 = 790 mg/L by oral administration to rats and NOAEL to humans as the chloride 

concentration of 0.5 ppm in inhalation exposure. Furthermore, in the case of high-concentration 

exposure, corrosivity or irritation to the skin and eyes may be generated. NOAEL of chronic 

toxicity of calcium hypochlorite by an animal test is 22.5 mg-chlorine/kg-bw/day. There is no 

report that calcium hypochlorite has carcinogenicity, mutagenicity, reproductive toxicity, or 

any effect on the endocrine system (see section 2.3 of this Basic Assessment Report). 

Furthermore, the risk to the human health by other additives among preparations except 

calcium hypochlorite and sodium sulfite, which is the neutralizer, is not considered. 

Bromoform which is a Relevant Chemical has an acute toxicity value of LD50 = 1, 147-1,550 mg/kg 

by oral administration in the animal test and causes irritation to the eyes and skin. In chronic 

exposure, it is reported that NOAEL in the oral administration test to the rat for 13 weeks 

is 25 mg/kg. The IARC evaluates the carcinogenicity as group 3 (the carcinogenicity to 

humans cannot be evaluated). Further, from the results of the animal test, the effects on 

mutagenicity and the reproductive toxicity in a dosage in which toxicity exists in a mother 

animal are suspected, but the effect on the endocrine system is not reported 

(see section 2.3 of this Basic Assessment Report). 
MEPC 61/2/6 

Annex, page 49 

I:\MEPC\61\2-6.doc 

In the case of the hazardousness of dibromochloromethane to the health, it is reported that the 

acute toxicity value by oral administration in the animal test is LD50 = 800 mg/kg - 1200 mg/kg 

and the acute toxicity value in the oral administration test to a mouse for 13 weeks is 

NOAEL = 30 mg/kg. The reproductive toxicity is suspected in the high-concentration test, but 

the IARC evaluates the carcinogenicity as group 3 (the carcinogenicity to humans cannot be 

evaluated). It is reported that the mutagenicity shows both positive and negative results. 

There are no data showing effects on the endocrine system (see 2.3 of this Basic 

Assessment Report). 

In the case of the acute effects of dichloromethane, it is reported that LD50 by the oral 

administration in the animal test is 1,710 - 2,250 mg/kg and LC50 by the inhalation exposure 

is approximately 50,000 mg/m3

, so that the acute effects by dichloromethane shows irritation 

to the skin and eyes. The effects are shown for NOAEL = 6 mg/kg-bw/day in the oral 

administration test to rats for two years and in a capacity of 25 ppm (88.3 mg/m3

) or more in 

the inhalation toxicity test to the rat for 100 days. Although test data indicating the 

reproductive toxicity cannot be acquired, the IARC classifies the carcinogenicity as group 2B 

(there is a possibility that the carcinogenicity exists with respect to humans), so that the 

mutagenicity is suspected. There is no report that dichloromethane shows an effect on the 

endocrine system (see section 2.3). 

Among monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic 

acid (which is halogenated acetic acid), monobromoacetic acid has the largest acute toxicity 

value and LD50 in the oral administration test to the rat was 177 mg/kg. Further, it represents 

the corrosivity/irritation. There are both positive and negative reports concerning reproductive 

toxicity and mutagenicity. An assessment result for the carcinogenicity by the international 

organization cannot be acquired, but for dibromoacetic acid, generation of a tumour is verified 

by animal tests. There are no data showing effects on the endocrine system (see section 2.3). 

For chloramines, LC50 in inhalation exposure test of trichloroamine to the rat is 112 ppm and 

NOAEL in the oral administration test of monochloroamine to the mouse for 90 days 

is 9.2 mg/kg-bw/day. There is no report that chloramines have carcinogenicity, mutagenicity, 

reproductive toxicity, and effects on the endocrine system (see section 2.3). 

In the case of dibromoacetonitrile, it is reported that LD50 by oral administration in animal 

tests is 245-361 mg/kg and the dibromoacetonitrile causes irritation to the skin, eyes, and 

respiration organisms due to the acute effects. NOAEL in the oral administration test to rats 

for 90 days is 11.3 mg/kg-bw/day. There is no data showing the reproductive toxicity, 

carcinogenicity, mutagenicity, and effects on the endocrine system (see section 2.3). 

7.2.2 Human exposure scenario (HES) 

In the BWMS, as a human exposure scenario (HES) of which health effects to the human are 

concerned, following a population, a unit operation, and an exposure route, an exposure 

frequency or duration with respect to the Active Substances and Relevant Chemicals are 

considered. 

7.2.2.1 Active Substances 

(i) Temporary dermal and inhalation exposure to the worker in storage, 

transportation, and handling in manual operation. 

(ii) Short-period inhalation exposure to the worker and the personnel by 

volatilization of residual Active Substances during a retention time in the 

ballast tank and temporary dermal exposure to the worker during a 

maintenance work, etc. 
MEPC 61/2/6 

Annex, page 50 

I:\MEPC\61\2-6.doc 

(iii) Dermal or oral exposure to the general public in surrounding waters after 

the ballast water is discharged. 

7.2.2.2 Relevant Chemicals 

(i) Short-period inhalation exposure to the worker and other personnel by 

volatilization of the Relevant Chemicals during the retention time in the 

ballast tank and temporary dermal and inhalation exposure to the worker 

during the maintenance work, etc. 

(ii) Dermal or oral exposure to the general public in surrounding waters after 

the ballast water is discharged. 

(iii) Chronic exposure to the general public through the food chain. 

A margin of exposure (MOE) is calculated for the above short-period inhalation exposure and 

temporary dermal and inhalation exposure. 

According to the result, MOEs of bromoform and dichloromethane are less than 100. 

However, since the hazardousness data is based on the chronic exposure and the exposure 

by the system is short-period and temporary, a simple comparison is difficult. Furthermore, 

the HES is based on the worst case and does not consider dilution by ventilation, so that it 

cannot be concluded that the health risk to the worker is directly generated by the MOE. 

In the HES, on an inhalation route, which is a major exposure route, ACGIH is set to 5.2 mg/m3

for bromoform and is 174 mg/m3

 for dichloromethane as a time weighted average (TWA) by 

an 8-hour weighted average. From comparison between the TWA and the estimated exposure 

concentration, the estimated exposure concentration (43.0 mg/m3

) is approximately 8.3 times 

more than the TWA for bromoform and the TWA is approximately five times more than the 

estimated exposure concentration (33.9 mg/m3

) for dichloromethane. From the above-mentioned 

results, even for dichloromethane, the concern of the health risk was low. For bromoform, 

the estimated exposure concentration is more than the TWA, but if the ventilation efficiency 

in the ballast tank is 10 times or more, the concentration becomes equal to or less than a 

concentration in which the health risk is concerned. Furthermore, since the TWA is an 

allowable concentration under a normal (chronic) exposure condition for a worker, a problem 

immediately does not occur with respect to temporary exposure in the system. 

For dibromochloromethane and dibromoacetonitrile, since their MOEs are more than 100 as 

the worst cases, the health risk to the worker is not concerned. 

Since the Relevant Chemicals include substances of which carcinogenicity, mutagenicity, 

and reproductive toxicity is doubted, ventilation should sufficiently be performed during the 

working in the ballast tank. At the same time, it is necessary to use the respiratory protective 

equipment, etc., and take measures to reduce the exposure concentration (ingestion dosage) 

to the workers as much as possible. 

Further, in in-ship space except the ballast tank, a concern of the health risk decreases as 

the Relevant Chemicals are further diluted in comparison with in-tank space. 

For dermal or oral exposure to the general public in surrounding waters after the ballast 

water is discharged, the exposure concentration in open general space is at a level which is 

not problematic in comparison with the exposure concentration in the ballast tank. 

For chronic exposure to the general public through the food chain, since logPow values of all 

the Relevant Chemicals are less than 3, the exposure to the general public through the food 

web is not concerned. 
MEPC 61/2/6 

Annex, page 51 

I:\MEPC\61\2-6.doc 

7.2.3 Assessment 

From the above-mentioned results, in the BWMS, it can be concluded that a concern of the 

health risk to the personnel (worker) and the general public by the Active Substances, 

Relevant Chemicals, and sodium sulfite used as the neutralizer is low. 

7.3 Risk to the aquatic environment 

As described in section 6 of this Basic Assessment Report, the ballast water discharged from 

the BWMS has almost no environmental effect. 

8 CONCLUSION 

An oxidizing substance, calcium hypochlorite, is used as the only Active Substance in this 

BWMS. In addition, although they are extremely small amounts, nine Relevant Chemicals 

are generated by the reaction between calcium hypochlorite and organisms. In this BWMS, 

calcium hypochlorite is stored in a fully safe method on board, and the safety of the ship and 

the personnel onboard are sufficiently ensured by wearing the protective equipment, etc., while 

the chemicals are handled. Furthermore, a risk effect to the general public and the environment 

around a discharge sea area is avoided through neutralization with sodium sulfite when the 

FAC concentration is more than 0.2 mg/L prior to discharge. Since the concentration of FAC 

is 0.2 mg/L or less after the neutralization in addition to low concentrations of the Relevant 

Chemicals, it is assessed that there is almost no environmental effect. Accordingly, it is 

considered that the BWMS satisfies the requirements for Basic Approval. 

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APPENDIX 1 

STATEMENT 

Example; Toxicity tests using three aquatic species for discharge water (high salinity, >32 psu) 

* * * 
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APPENDIX 2 

QUALITY ASSURANCE STATEMENT 
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